SMPC Search
Records: 446
| ID | Medicinal Product Name | Composition - Active | Dose Form | Authorisation Holder | Auth Number | Auth Date | Last Revision | Details |
|---|---|---|---|---|---|---|---|---|
| 617 | Apexelsin 5 mg/ml powder for dispersion for infusion. | Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles. After reconstitution, each ml of dispersion contains 5 mg paclitaxel formulated as albumin bound nanoparticles. For the full list of excipients, see section 6.1. | Powder for dispersion for infusion The reconstituted dispersion has a pH of 6.0-7.5 and an osmolality of 300-360 mOsm/kg. The product is white to yellow lyophilized cake or powder. | WhiteOak Pharmaceutical B.V. Teleportboulevard 130, Amsterdam, 1043 EJ, Netherlands | PLGB 59801/0001 | Oct. 16, 2024 | April 11, 2025 | See Details |
| 616 | Byfavo 20 mg powder for solution for injection | Each vial contains remimazolam besylate equivalent to 20 mg remimazolam. After reconstitution each mL contains 2.5 mg remimazolam. Excipient with known effect Each vial contains 79.13 mg of dextran 40 for injection. For the full list of excipients, see section 6.1. | Powder for solution for injection. White to off-white powder. | PAION Pharma GmbH Heussstraße 25 52078 Aachen Germany | PLGB 59768/0001 | June 28, 2021 | Aug. 20, 2024 | See Details |
| 615 | Instanyl 50 micrograms nasal spray, solution in single-dose container | Instanyl 50 micrograms nasal spray, solution in single-dose container Each single-dose container contains one dose (100 microlitres) of fentanyl citrate equivalent to 50 micrograms fentanyl. For the full list of excipients, see section 6.1. | Nasal spray, solution (nasal spray). Clear, colourless solution. | Istituto Gentili S.r.l. Via San Giuseppe Cottolengo 15 20143 Milan Italy | PLGB 59384/0011 | Jan. 1, 2021 | Oct. 7, 2024 | See Details |
| 614 | Instanyl 200 micrograms nasal spray, solution in single-dose container | Instanyl 200 micrograms nasal spray, solution in single-dose container Each single-dose container contains one dose (100 microlitres) of fentanyl citrate equivalent to 200 micrograms fentanyl. For the full list of excipients, see section 6.1. | Nasal spray, solution (nasal spray). Clear, colourless solution. | Istituto Gentili S.r.l. Via San Giuseppe Cottolengo 15 20143 Milan Italy | PLGB 59384/0010 | Jan. 1, 2021 | Oct. 7, 2024 | See Details |
| 613 | Duerta 5 microgram/hour, transdermal patch. | Each transdermal patch contains 5 mg of buprenorphine in a 6.25 cm2 area releasing a nominal 5 micrograms of buprenorphine per hour over a period of 7 days. For the full list of excipients, see section 6.1. | Transdermal patch. Square, beige coloured patch with rounded corners marked: Duerta 5 µg/h | Mundipharma Corporation (Ireland) Limited United Drug House Magna Drive Magna Business Park Citywest Road Dublin 24 Ireland | PLGB 59242/0001 | July 30, 2024 | April 10, 2025 | See Details |
| 612 | Nepexto 50 mg solution for injection in pre-filled pen | Nepexto 50 mg solution for injection in pre-filled pen Each pre-filled pen contains 50 mg of etanercept. Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system. For the full list of excipients, see section 6.1. | Solution for injection (injection). The solution is clear to opalescent, colourless to yellow and is formulated at pH 6.3 ± 0.2. The osmolality of the solution is 310 ± 30 mOsm/kg. | Biosimilar Collaborations Ireland Limited Unit 35/36 Grange Parade Baldoyle Industrial Estate Dublin 13 Dublin D13 R20R Ireland | PLGB 58141/0011 | Jan. 7, 2025 | May 16, 2025 | See Details |
| 611 | Nepexto 50 mg solution for injection in pre-filled syringe | Nepexto 50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of etanercept. Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system. For the full list of excipients, see section 6.1. | Solution for injection (injection). The solution is clear to opalescent, colourless to yellow and is formulated at pH 6.3 ± 0.2. The osmolality of the solution is 310 ± 30 mOsm/kg. | Biosimilar Collaborations Ireland Limited Unit 35/36 Grange Parade Baldoyle Industrial Estate Dublin 13 Dublin D13 R20R Ireland | PLGB 58141/0010 | Jan. 7, 2025 | May 16, 2025 | See Details |
| 610 | Ogivri 150 mg powder for concentrate for solution for infusion | Ogivri 150 mg powder for concentrate for solution for infusion One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures. The reconstituted Ogivri solution contains 21 mg/mL of trastuzumab. Excipient with known effect Each 150 mg vial contains 115.2 mg sorbitol (E420). For the full list of excipients, see section 6.1. | Powder for concentrate for solution for infusion (powder for concentrate). White to pale yellow lyophilised powder. | Biosimilar Collaborations Ireland Limited Unit 35/36 Grange Parade Baldoyle Industrial Estate Dublin 13 Dublin D13 R20R Ireland | PLGB 58141/0001 | Oct. 9, 2025 | Oct. 9, 2025 | See Details |
| 609 | Strimvelis 1-10 million cells/ml dispersion for infusion. | General description An autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells. The finished product is composed of one or more ethylene vinyl acetate (EVA) bags which contain an autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence. The quantitative information regarding CD34+ cells/kg and total cells in the product is presented in the labelling for each batch. The concentration is 1-10 million CD34+ cells/ml. Excipient with known effect This medicinal product contains 0.15 mmol sodium per ml (see section 4.4). For the full list of excipients, see section 6.1. | Dispersion for infusion. A cloudy to clear, colourless to pink dispersion of cells. | Fondazione Telethon ETS Via Varese 16/B 00185 Rome Italy | PLGB 58042/0001 | Jan. 1, 2021 | June 21, 2023 | See Details |
| 608 | - Sugammadex 100 mg/mL solution for injection | 1 mL contains sugammadex sodium equivalent to 100 mg sugammadex. Excipients with known effect Contains up to 9.7 mg/mL sodium (see section 4.4). For the full list of excipients, see section 6.1. | Solution for injection. Clear and colourless to slightly yellow solution. The pH is between 7 and 8 and osmolality is between 300 and 500 mOsm/kg. | Extrovis EU Ltd. Pátriárka utca 14. 2000, Szentendre Hungary | PLGB 57832/0001 | Dec. 14, 2023 | Feb. 25, 2025 | See Details |
| 607 | Hyftor 2 mg/g gel | Each gram of gel contains 2 mg of sirolimus. Excipient with known effect Each gram of gel contains 458 mg of ethanol. For the full list of excipients, see section 6.1. | Gel Colourless transparent gel. | Plusultra pharma GmbH, Fritz-Vomfelde-Str. 36 40547 Düsseldorf Germany | PLGB 57572/0001 | Sept. 1, 2023 | Dec. 14, 2023 | See Details |
| 606 | Spherox 10-70 spheroids/cm2 implantation suspension | 2.1 General description Spheroids of human autologous matrix-associated chondrocytes for implantation suspended in isotonic sodium chloride solution. 2. Spheroids are spherical aggregates of ex vivo expanded human autologous chondrocytes and self-synthesized extracellular matrix. Each pre-filled syringe or applicator contains a specific number of spheroids according to the defect size (10-70 spheroids/cm2) to be treated. For the full list of excipients, see section 6.1. | Implantation suspension. White to yellowish spheroids of matrix-associated autologous chondrocytes in a clear, colourless solution. | CO.DON GmbH Deutscher Platz 5d 04103 Leipzig Germany | PLGB 57261/0001 | Sept. 1, 2025 | Sept. 1, 2025 | See Details |
| 605 | Levorol 5 mg/ml Oral Solution | Each ml contains 5 mg levomepromazine (as hydrochloride). Excipients with known effect Each ml contains 150.95 mg propylene glycol, 0.30 mg sodium benzoate and 0.03 mg benzyl alcohol. For the full list of excipients, see section 6.1. | Oral Solution Clear, colourless to slightly pinkish-orangish solution with orange odour. | Galvany Pharma Ltd Business & Technology Centre Bessemer Drive, Stevenage SG1 2DX, UK | PLGB 56809/0001 | June 15, 2022 | March 8, 2024 | See Details |
| 604 | Aeronate 27.5 micrograms per spray, nasal spray suspension | Each spray actuation delivers 27.5 micrograms of fluticasone furoate. Excipient with known effect Benzalkonium chloride 0.165 mg/ml For the full list of excipients, see section 6.1. | Nasal spray, suspension. It is a white homogeneous suspension. | Abdi Farma GmbH Donnersbergstraße 4 64646 Heppenheim Germany | PLGB 56740/0001 | Nov. 13, 2024 | Oct. 14, 2025 | See Details |
| 603 | Ciclesonide ADVANZ PHARMA 80 mcg per metered dose pressurised inhalation, solution | Ciclesonide ADVANZ PHARMA 80 mcg per metered dose pressurised inhalation, solution: 1 actuation (delivered dose from the mouthpiece) contains 80 micrograms of ciclesonide The canisters are fitted into plastic actuators incorporating an atomising orifice and fitted with green dust cap. Excipient with known effect: 1 actuation contains 4.7 mg of ethanol For the full list of excipients, see section 6.1. | Pressurised inhalation, solution Clear and colourless | Advanz Pharma Limited Unit 17 Northwood House Northwood Crescent Dublin 9 D09 V504 Ireland | PLGB 56734/0011 | April 25, 2024 | April 25, 2024 | See Details |
| 602 | Zokinvy 75 mg hard capsules | Each capsule contains 75 mg lonafarnib. For the full list of excipients, see section 6.1. | Hard capsule (capsule) Size 3 hard capsule (6 mm x 16 mm), opaque light orange with “LNF and “75” printed in black. | EigerBio Europe Ltd. 1 Castlewood Avenue Rathmines, D06 H685, Ireland | PLGB 56709/0002 | Aug. 24, 2022 | Jan. 31, 2024 | See Details |
| 601 | Zokinvy 50 mg hard capsules | Each capsule contains 50 mg lonafarnib. For the full list of excipients, see section 6.1. | Hard capsule (capsule) Size 4 hard capsule (5 mm x 14 mm), opaque yellow with “LNF” and “50” printed in black. | EigerBio Europe Ltd. 1 Castlewood Avenue Rathmines, D06 H685, Ireland | PLGB 56709/0001 | Aug. 24, 2022 | Jan. 31, 2024 | See Details |
| 600 | Livmarli 9.5 mg/mL oral solution | Each mL of solution contains maralixibat chloride equivalent to 9.5 mg maralixibat. Excipient with known effect Each mL of oral solution contains 364.5 mg propylene glycol (E1520) For the full list of excipients, see section 6.1. | Oral solution. Clear, colourless to light-yellow liquid. | Mirum Pharmaceuticals International B.V. Kingsfordweg 151 1043 GR Amsterdam, Netherlands | PLGB 56642/0001 | Feb. 10, 2023 | Jan. 8, 2026 | See Details |
| 599 | Suxamethonium Chloride 50mg/ml Solution for Injection | Each ml of solution for injection contains 50 mg of suxamethonium chloride dihydrate (equivalent to 36.55 mg of suxamethonium) Each 2 ml vial contains 100 mg of suxamethonium chloride dihydrate (equivalent to 73.1 mg of suxamethonium). For the full list of excipients, see section 6.1. | Solution for Injection. Clear, colourless, sterile solution. pH of the solution: 3.0 - 5.0 Osmolality: 280 – 365 mOsmol/kg | Medsurge Healthcare UK Ltd, 209 The Heights, Northolt, UB5 4BX, England | PLGB 56501/0001 | Dec. 18, 2024 | Dec. 12, 2025 | See Details |
| 598 | Fluorescein 100 mg/ml Solution for injection | 1 ml solution contains 100 mg fluorescein (as 113.2 mg fluorescein sodium) One 5 ml vial contains 500 mg fluorescein (as 566 mg fluorescein sodium) Excipient with known effect: Sodium (as fluorescein sodium and sodium hydroxide) 3.15 mmol dose. For a full list of excipients, see section 6.1. | Solution for injection Clear, red-orange solution | Linus Pharma LTD Unit 408 Screenworks 22 Highbury Grove London England N5 2ER | PLGB 56448/0001 | Aug. 22, 2023 | Aug. 22, 2023 | See Details |
| 597 | Ontozry 12.5 mg tablets | Each tablet contains 12.5 mg cenobamate. Excipient with known effect Each 12.5 mg tablet contains 39.7 mg lactose monohydrate. For the full list of excipients, see section 6.1. | Tablet Uncoated round white to off-white tablet with AV on one side and ‘12’ on the other side | Angelini Pharma UK-I Limited 6th Floor, Napier House 24 High Holborn London WC1V 6AZ United Kingdom | PLGB 56215/0001 | Jan. 27, 2026 | Jan. 27, 2026 | See Details |
| 596 | Yellox 0.9 mg/ml eye drops solution | 1 ml of solution contains 0.9 mg bromfenac (as sodium sesquihydrate). One drop contains approximately 33 micrograms bromfenac. Excipient(s) with known effect: Each ml of solution contains 50 micrograms of benzalkonium chloride. For the full list of excipients, see section 6.1. | Eye drops, solution. Clear yellow solution. pH: 8.0-8.5; osmolality: 270-310 mOsmol/kg | Bausch + Lomb Ireland Limited 3013 Lake Drive Citywest Business Campus Dublin 24, D24PPT3 Ireland | PLGB 56094/0001 | Jan. 1, 2021 | April 7, 2025 | See Details |
| 595 | ZTALMY 50 mg/mL oral suspension | Each mL of oral suspension contains 50 mg of ganaxolone. Excipients with known effect Each mL of oral suspension contains: - 0.92 mg of sodium benzoate - 0.00068 mg benzoic acid - 0.00023 mg benzyl alcohol - 1.02 mg methyl parahydroxybenzoate - 0.2 mg propyl parahydroxybenzoate For the full list of excipients, see section 6.1. | Oral suspension. White to off-white suspension. | Marinus Pharmaceuticals Emerald Limited 10 Earlsfort Terrace Dublin 2 D02 T380 Ireland | PLGB 55682/0001 | March 7, 2024 | Jan. 9, 2025 | See Details |
| 594 | IMCIVREE 10 mg/ml solution for injection | 1 ml of solution contains 10 mg of setmelanotide. Each vial contains 10 mg setmelanotide in 1 ml of solution for injection. Excipient(s) with known effect 1 ml of solution contains 10 mg benzyl alcohol. For the full list of excipients, see section 6.1. | Solution for injection (injection) Clear to slightly opalescent, colourless to slightly coloured solution. | Rhythm Pharmaceuticals Netherlands B.V. Radarweg 29, 1043NX Amsterdam, Netherlands | PLGB 55587/0001 | Sept. 15, 2021 | Aug. 7, 2025 | See Details |
| 593 | TAVOCTAME 2g/0.25g powder for solution for infusion. | Each vial contains 2 g piperacillin (as sodium salt) and 0.25 g tazobactam (as sodium salt). Excipient with known effect One vial of Tavoctame 2g/0.25g powder for solution for infusion contains 4.7 mmol (108 mg) of sodium. For the full list of excipients, see section 6.1. | Powder for solution for infusion. White to off white powder. | COOPER S.A. 64 Aristovoulou , 11853, Athens Greece | PLGB 55461/0001 | Feb. 22, 2024 | Feb. 22, 2024 | See Details |
| 592 | Bevqolva 25 mg/mL concentrate for solution for infusion. | Each mL of concentrate contains 25 mg of bevacizumab*. Each 4 mL vial contains 100 mg of bevacizumab. Each 16 mL vial contains 400 mg of bevacizumab. For dilution and other handling recommendations, see section 6.6. *Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells. For the full list of excipients, see section 6.1. | Concentrate for solution for infusion. Clear to slightly opalescent, colourless to pale brown liquid. | CuraTeQ Biologics s.r.o Trtinova 260/1, Cakovice, 19600 Prague 9 Czech Republic | PLGB 55348/0001 | Dec. 20, 2024 | See Details | |
| 591 | Taltz® 80 mg solution for injection in pre filled syringe | Each pre filled syringe contains 80 mg ixekizumab in 1 ml. Ixekizumab is produced in CHO cells by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection (injection). The solution is clear and colourless to slightly yellow. | Eli Lilly and Company (Ireland) Limited, Dunderrow, Kinsale, Co. Cork, Ireland. | PLGB 55318/0001 | Jan. 1, 2021 | Jan. 21, 2026 | See Details |
| 590 | Taltz 80 mg solution for injection in pre-filled pen | Each pre-filled pen contains 80 mg ixekizumab in 1 ml. Ixekizumab is produced in CHO cells by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection. The solution is clear and colourless to slightly yellow. | Eli Lilly and Company (Ireland) Limited, Dunderrow, Kinsale, Co. Cork, Ireland. | PLGB 55318/0001 | Jan. 1, 2021 | Jan. 21, 2026 | See Details |
| 589 | Rubraca 200 mg film-coated tablets | Rubraca 200 mg film-coated tablets Each tablet contains rucaparib camsylate corresponding to 200 mg rucaparib. a. For the full list of excipients, see section 6.1. | Film-coated tablet. Rubraca 200 mg film-coated tablet Blue, 11 mm, round film-coated tablet, debossed with “C2”. | pharmaand GmbH Taborstrasse 1 1020 Vienna Austria | PLGB 54599/0011 | May 2, 2024 | See Details | |
| 588 | Farydak 20 mg hard capsules | Each hard capsule contains panobinostat lactate anhydrous equivalent to 20 mg panobinostat. For the full list of excipients, see section 6.1. | Hard capsule (capsule). Red opaque hard gelatin capsule (19.1–19.7 mm) containing white to almost white powder, with radial marking “LBH 20 mg” in black ink on cap and two radial bands in black ink on body. | pharmaand GmbH Taborstrasse 1 1020 Vienna Austria | PLGB 54599/0010 | Jan. 1, 2021 | Nov. 24, 2023 | See Details |
| 587 | Emselex 15 mg prolonged-release tablets | Each tablet contains 15 mg of darifenacin (as hydrobromide) For the full list of excipients, see section 6.1. | Prolonged-release tablet Light peach round, convex tablet debossed with “DF” on one side and “15” on the reverse. | pharmaand GmbH Taborstrasse 1 1020 Vienna Austria | PLGB 54599/0001 | Jan. 1, 2021 | Jan. 2, 2026 | See Details |
| 586 | Cuprymina 925 MBq/mL radiopharmaceutical precursor, solution | Each mL of solution contains 925 MBq of copper (64Cu) chloride at calibration time (01h00 a.m. Central European Time [CET]), corresponding to at least 0.25 micrograms of Copper-64. The calibration time is set between the end of the synthesis time and the expiry time. Each vial contains an activity ranging from 925 MBq to 2,770 MBq (at calibration time) which corresponds to an amount of 0.25 to 0.75 micrograms of Copper-64. The volume varies from 1 to 3 mL. The minimal specific activity is 3,700 MBq Copper-64/micrograms of Copper at the expiry date and time. Copper-64 has a half-life of 12.7 hours. Copper-64 decays by an emission of ß+ (17.6 %) with a maximum energy of 0.66 MeV, an emission of ß- (38.5 %) with a maximum energy of 0.58 MeV and electronic capture (43.9 %). Copper-64 decays in stable Nickel 64Ni (61 %) by an emission of ß+ (18 %) or by an electronic capture (43 %). Copper-64 decays also in stable Zinc (64Zn) by emission of ß- (39 %). For the full list of excipients, see section 6.1. | Radiopharmaceutical precursor, solution. Clear, colourless solution, free of particulate matter. | A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L. Località Cavallino 39 A/B 62010 Montecosaro (MC) Italy Tel.: 0039.0733.229739 Fax: 0039.0733.560352 E-mail: amministrazione@acompet.it | PLGB 54395/0001 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 585 | Namuscla 167 mg hard capsules | Each capsule contains mexiletine hydrochloride corresponding to 166.62 mg mexiletine For the full list of excipients, see section 6.1. | Hard capsule (capsule). Namuscla capsules are Swedish orange hard shell gelatin capsules (20 mm) filled with white powder. | Lupin Europe GmbH Hanauer Landstraße 139-143, 60314 Frankfurt am Main Germany | PLGB 54289/0001 | Jan. 1, 2021 | Jan. 14, 2026 | See Details |
| 584 | HETLIOZ 20 mg hard capsules | Each hard capsule contains 20 mg tasimelteon. Excipients with known effect Each hard capsule contains 183.25 mg of lactose (as anhydrous) and 0.03 mg of Orange Yellow S (E110). For the full list of excipients, see section 6.1. | Hard capsule Dark blue opaque, hard capsule (dimensions 19.4 mm x 6.9 mm) marked with ‘VANDA 20 mg’ in white ink. | Vanda Pharmaceuticals Netherlands B.V. Prins Bernhardplein 200 1097 JB Amsterdam The Netherlands | PLGB 54231/0001 | Jan. 1, 2021 | See Details | |
| 583 | Eliquis 2.5 mg film-coated tablets | Each film-coated tablet contains 2.5 mg apixaban. Excipient(s) with known effect Each 2.5 mg film-coated tablet contains 51.4 mg lactose (see section 4.4). For the full list of excipients, see section 6.1. | Film-coated tablet (tablet) Yellow, round tablets (diameter of 5.95 mm) debossed with 893 on one side and 2½ on the other side. | Bristol-Myers Squibb/Pfizer EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland | PLGB 54213/0001 | Jan. 4, 2024 | See Details | |
| 582 | Vistadot 0.5 mmol/ml solution for injection. | 1 ml solution for injection contains 279.3 mg gadoteric acid (as meglumine salt) equivalent to 0.5 mmol equivalent to 202.46 mg of gadolinium oxide and 90.62 mg of tetraxetan (DOTA) Gadoteric acid: gadolinium complex with1,4,7,10 tetraazacyclododecane N,N’,N”,N’’’ tetraacetic acid (tetraxetan (DOTA)) For the full list of excipients, see section 6.1 | Solution for injection. Clear, colourless to light yellow solution with pH 6.9-7.8, viscosity of 1.70- 2.20 mPa.s at 37°C and osmolality of 1.1-1.7 osmol/kg at 37°C. | Vantage Pharmaceuticals Ltd. Ravalco House, Cleveland Way, Hemel Hempstead, Hertfordshire, HP2 7DL United Kingdom | PLGB 54054/0001 | Oct. 17, 2022 | Jan. 2, 2025 | See Details |
| 581 | Fesoterodine fumarate 8 mg Prolonged-release Tablets | Each prolonged-release tablet contains 8 mg fesoterodine fumarate corresponding to 6.2 mg of fesoterodine. Excipients with known effect Each prolonged-release tablet contains 72.0 mg of fructose and 55.48 mg of lactose. For the full list of excipients, see section 6.1. | Prolonged-release tablet. Dark blue elliptical, biconvex and debossed with “F8” on one side. | Celix Pharma Ltd 12 Constance Street London E16 2DQ United Kingdom | PLGB 53835/0033 | Sept. 1, 2023 | Dec. 15, 2023 | See Details |
| 580 | Fesoterodine fumarate 4 mg Prolonged-release Tablets | Each prolonged-release tablet contains 4 mg fesoterodine fumarate corresponding to 3.1 mg of fesoterodine. Excipients with known effect Each prolonged-release tablet contains 72.0 mg of fructose and 58.07 mg of lactose. For the full list of excipients, see section 6.1. | Prolonged-release tablet. Blue elliptical, biconvex and debossed with “F4” on one side. | Celix Pharma Ltd 12 Constance Street London E16 2DQ United Kingdom | PLGB 53835/0032 | Sept. 1, 2023 | Dec. 15, 2023 | See Details |
| 579 | Rivaroxaban 2.5 mg Film-coated Tablets | Each film-coated tablet contains 2.5 mg rivaroxaban. Excipient with known effect Each film-coated tablet contains 28.090 mg lactose (as monohydrate), see section 4.4. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Rivaroxaban 2.5 mg Tablets are light-yellow, round shaped, biconvex, film-coated tablets (approximately 6.1 mm in diameter), debossed with “C7” on one side and plain on other side. | Celix Pharma Ltd 12 Constance Street London E16 2DQ, United Kingdom | PLGB 53835/0011 | Aug. 31, 2022 | May 14, 2024 | See Details |
| 578 | Tapentadol Celix 250 mg Prolonged-release Tablets Vecicom 250 mg Prolonged-release Tablets | Each prolonged-release tablet contains 382.848 mg of tapentadol phosphate equivalent to 250 mg tapentadol (free base of tapentadol). For a full list of excipients, see section 6.1. | Prolonged-release Tablets. Reddish brown, oblong, biconvex film-coated tablet (8.7 mm x 18.2 mm) with score lines on both sides. The score line is not intended for breaking the tablet. | Celix Pharma Ltd., 12 Constance Street, London E16 2DQ, United Kingdom | PLGB 53835/0010 | Feb. 22, 2023 | June 28, 2023 | See Details |
| 577 | Pirfenidone 267 mg Film-coated Tablets | The active ingredient is pirfenidone. Each film-coated tablet contains 267 mg of pirfenidone Excipients with known effect: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free’. For a full list of excipients, see section 6.1. | Film-coated Tablets Pirfenidone 267 mg Film-coated Tablets are light yellow to yellow coloured, oval shaped tablets, debossed with “A106” on one side and plain on the other side. | Celix Pharma Ltd., 12 Constance street, London E16 2DQ, United Kingdom | PLGB 53835/0001 | Nov. 5, 2021 | Nov. 4, 2024 | See Details |
| 576 | Gencebok 10 mg/ml solution for infusion | Each ml contains 10 mg caffeine citrate (equivalent to 5 mg caffeine). Each 1 ml ampoule contains 10 mg caffeine citrate (equivalent to 5 mg caffeine). For the full list of excipients, see section 6.1. | Solution for infusion. Clear, colourless, aqueous solution, with a pH of 4.8 and an osmolality of 65 to 95 mOsm/kg. | Gennisium Pharma Swen Parc de Vitrolles Chemin de la Bastide Blanche 13127 Vitrolles - France | PLGB 53809/0001 | Jan. 1, 2021 | July 13, 2023 | See Details |
| 575 | Neuraceq 300 MBq/mL solution for injection | Each mL of solution for injection contains 300 MBq of florbetaben (18F) at the date and time of calibration. The activity per vial ranges from 300 MBq to 3000 MBq at the date and time of calibration. Fluorine (18F) decays to stable oxygen (18O) with a half-life of approximately 110 minutes by emitting a positron radiation of 634 keV, followed by photonic annihilation radiation of 511 keV. Excipient(s) with known effect This medicinal product contains up to 1.2 g of ethanol and up to 33 mg of sodium per dose (see section 4.4). For the full list of excipients, see section 6.1. | Solution for injection. Clear colourless solution. | Life Molecular Imaging Limited 25 Barnes Wallis Road Fareham Hampshire, PO15 5TT United Kingdom | PLGB 53758/0001 | Jan. 1, 2021 | Feb. 19, 2025 | See Details |
| 574 | Spikevax XBB.1.5 0.1 mg/mL dispersion for injection | This is a multidose vial that contains 5 doses of 0.5 mL each or 10 doses of 0.25 mL each. One dose (0.5 mL) contains 50 micrograms of andusomeran, a COVID-19 mRNA Vaccine (embedded in SM-102 lipid nanoparticles). One dose (0.25 mL) contains 25 micrograms of andusomeran, a COVID-19 mRNA Vaccine (embedded in lipid nanoparticles). Andusomeran is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 (XBB.1.5). For the full list of excipients, see section 6.1. | Dispersion for injection White to off white dispersion (pH: 7.0 – 8.0). | MODERNA BIOTECH SPAIN, S.L. C/ Julián Camarillo n ° 31 28037 Madrid Spain | PLGB 53720/0011 | Sept. 14, 2023 | March 21, 2025 | See Details |
| 573 | Zynrelef (60 mg + 1.8 mg) / 2.3 mL prolonged-release wound solution | Each mL of solution contains 29.25 mg of bupivacaine and 0.88 mg of meloxicam. Zynrelef prolonged-release solution is provided in the following doses: • 60 mg/1.8 mg of bupivacaine/meloxicam. • 200 mg/6 mg of bupivacaine/meloxicam. • 400 mg/12 mg of bupivacaine/meloxicam. For the full list of excipients, see section 6.1. | Prolonged-release wound solution. Clear, pale yellow to yellow, viscous liquid. | Heron Therapeutics, B.V. Herengracht 500 1017 CB Amsterdam Netherlands | PLGB 53712/0001 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 572 | Xenleta 150 mg concentrate and solvent for solution for infusion | Each vial of concentrate contains lefamulin acetate equivalent to 150 mg of lefamulin in 15 mL of normal saline (0.9% sodium chloride), to be diluted to a final concentration of 0.6 mg/mL. Excipients with known effect This medicinal product contains 1,055 mg sodium per dose, equivalent to 52.75% of the WHO recommended maximum daily intake of 2 g sodium for an adult. For the full list of excipients, see section 6.1. | Concentrate and solvent for solution for infusion. The concentrate is a colourless solution. The solvent is a colourless solution. | Nabriva Therapeutics Ireland DAC Alexandra House, Office 225/227 The Sweepstakes Ballsbridge Dublin 4 D04 C7H2 Ireland | PLGB 53672/0001 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 571 | ELZONRIS 1 mg/mL concentrate for solution for infusion | 1 mL of concentrate for solution for infusion contains 1 mg tagraxofusp. Each vial contains 1 mg of tagraxofusp. Tagraxofusp is a diphtheria toxin-interleukin-3 (IL-3) fusion protein produced by recombinant DNA technology in Escherichia coli. Excipient with known effect Each vial contains 50 mg of sorbitol (E420). For the full list of excipients, see section 6.1. | Concentrate for solution for infusion (sterile concentrate). Clear, colourless liquid. A few white to translucent particles may be present. | Stemline Therapeutics B.V. Basisweg 10, 1043 AP Amsterdam Netherlands | PLGB 53425/0001 | Oct. 15, 2021 | Nov. 16, 2022 | See Details |
| 570 | Holoclar 79,000 - 316,000 cells/cm2 living tissue equivalent | 2.1 General description Ex vivo expanded autologous human corneal epithelial cells containing stem cells. 2. Holoclar consists of a transparent circular sheet of 300,000 to 1,200,000 viable autologous human corneal epithelial cells (79,000 - 316,000 cells/ cm2), including on average 3.5 % (0.4 to 16 %) limbal stem cells, and stem cell-derived transient amplifying and terminally differentiated cells, attached on a supportive 2.2 cm diameter fibrin layer and maintained in the transport medium. For the full list of excipients, see section 6.1. | Living tissue equivalent. Transparent, circular sheet. | Holostem Terapie Avanzate s.r.l. Via Glauco Gottardi 100 41125 Modena Italy Telephone: +39 059 2058070 Telefax: +39 059 2058115 | PLGB 53298/0001 | Jan. 12, 2022 | Jan. 27, 2023 | See Details |
| 569 | Temodal® 5 mg hard capsules | 5 mg hard capsules Each hard capsule contains 5 mg temozolomide. Excipient(s) with known effect: Each hard capsule contains 132.8 mg of anhydrous lactose. For the full list of excipients, see section 6.1. | 5 mg hard capsule (capsule). The hard capsules have an opaque white body, an opaque green cap, and are imprinted with black ink. The cap is imprinted with “TEMODAL”. The body is imprinted with “5 mg”, the Schering-Plough logo and two stripes. | Merck Sharp & Dohme (UK) Limited 120 Moorgate London EC2M 6UR United Kingdom | PLGB 53095/0073 | Jan. 1, 2021 | Aug. 19, 2021 | See Details |
| 568 | Temodal® 250 mg hard capsules | 250 mg hard capsules Each hard capsule contains 250 mg temozolomide. Excipient(s) with known effect: Each hard capsule contains 154.3 mg of anhydrous lactose. For the full list of excipients, see section 6.1. | 250 mg hard capsule (capsule) The hard capsules have an opaque white body and cap, and are imprinted with black ink. The cap is imprinted with “TEMODAL”. The body is imprinted with “250 mg”, the Schering-Plough logo and two stripes. | Merck Sharp & Dohme (UK) Limited 120 Moorgate London EC2M 6UR United Kingdom | PLGB 53095/0072 | Jan. 1, 2021 | Aug. 19, 2021 | See Details |
| 567 | Temodal® 20 mg hard capsules | 20 mg hard capsules Each hard capsule contains 20 mg temozolomide. Excipient(s) with known effect: Each hard capsule contains 182.2 mg of anhydrous lactose. For the full list of excipients, see section 6.1. | 20 mg hard capsule (capsule) The hard capsules have an opaque white body, an opaque yellow cap, and are imprinted with black ink. The cap is imprinted with “TEMODAL”. The body is imprinted with “20 mg”, the Schering-Plough logo and two stripes. | Merck Sharp & Dohme (UK) Limited 120 Moorgate London EC2M 6UR United Kingdom | PLGB 53095/0071 | Jan. 1, 2021 | Aug. 19, 2021 | See Details |
| 566 | Temodal® 180 mg hard capsules | 180 mg hard capsules Each hard capsule contains 180 mg temozolomide. Excipient(s) with known effect: Each hard capsule contains 316.3 mg of anhydrous lactose. For the full list of excipients, see section 6.1. | 180 mg hard capsule (capsule) The hard capsules have an opaque white body, an opaque orange cap, and are imprinted with black ink. The cap is imprinted with “TEMODAL”. The body is imprinted with “180 mg”, the Schering-Plough logo and two stripes. | Merck Sharp & Dohme (UK) Limited 120 Moorgate London EC2M 6UR United Kingdom | PLGB 53095/0070 | Jan. 1, 2021 | Aug. 19, 2021 | See Details |
| 565 | Temodal® 140 mg hard capsules | 140 mg hard capsules Each hard capsule contains 140 mg temozolomide. Excipient(s) with known effect: Each hard capsule contains 246 mg of anhydrous lactose. For the full list of excipients, see section 6.1. | 140 mg hard capsule (capsule) The hard capsules have an opaque white body, a blue cap, and are imprinted with black ink. The cap is imprinted with “TEMODAL”. The body is imprinted with “140 mg”, the Schering-Plough logo and two stripes. | Merck Sharp & Dohme (UK) Limited 120 Moorgate London EC2M 6UR United Kingdom | PLGB 53095/0069 | Jan. 1, 2021 | Aug. 19, 2021 | See Details |
| 564 | Temodal® 100 mg hard capsules | 100 mg hard capsules Each hard capsule contains 100 mg temozolomide. Excipient(s) with known effect: Each hard capsule contains 175.7 mg of anhydrous lactose. For the full list of excipients, see section 6.1. | 100 mg hard capsule (capsule) The hard capsules have an opaque white body, an opaque pink cap, and are imprinted with black ink. The cap is imprinted with “TEMODAL”. The body is imprinted with “100 mg”, the Schering-Plough logo and two stripes. | Merck Sharp & Dohme (UK) Limited 120 Moorgate London EC2M 6UR United Kingdom | PLGB 53095/0068 | Jan. 1, 2021 | Aug. 19, 2021 | See Details |
| 563 | Bridion 100 mg/mL solution for injection | 1 mL contains sugammadex sodium equivalent to 100 mg sugammadex. Each vial of 2 mL contains sugammadex sodium equivalent to 200 mg sugammadex. Each vial of 5 mL contains sugammadex sodium equivalent to 500 mg sugammadex. Excipient(s) with known effect Contains up to 9.7 mg/mL sodium (see section 4.4). For the full list of excipients, see section 6.1. | Solution for injection (injection). Clear and colourless to slightly yellow solution. The pH is between 7 and 8 and osmolality is between 300 and 500 mOsm/kg. | Merck Sharp & Dohme (UK) Limited 120 Moorgate London EC2M 6UR United Kingdom | PLGB 53095/0010 | Jan. 1, 2021 | May 8, 2025 | See Details |
| 562 | Ogluo 1 mg solution for injection in pre-filled syringe. | Each pre-filled syringe contains 1 mg glucagon in 0.2 mL. For the full list of excipients, see section 6.1. | Solution for injection (injection) A clear, colourless to pale yellow solution. | Tetris Pharma Ltd. 14 North Street Mears Ashby Northants NN6 0DW UK | PLGB 52808/0010 | April 23, 2021 | April 27, 2023 | See Details |
| 561 | Pyrukynd 5 mg film-coated tablets | Each film-coated tablet contains 5 mg of mitapivat (as sulfate). Excipient with known effect Each film-coated tablet contains 0.3 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. | Film-coated tablet Blue, round film-coated tablets of approximately 5 mm in diameter with “M5” printed in black ink on one side and plain on the reverse. | Agios Netherlands B.V. Zuidplein 36 Regus Amsterdam WTC 1077XV Amsterdam The Netherlands | PLGB 52779/0001 | Dec. 20, 2022 | Dec. 20, 2022 | See Details |
| 560 | Ebvallo 2.8 × 107 – 7.3 × 107 cells/mL dispersion for injection | 2.1 General description Ebvallo (tabelecleucel) is an allogeneic Epstein-Barr virus (EBV)-specific T-cell immunotherapy which targets and eliminates EBV-positive cells in a human leukocyte antigen (HLA)-restricted manner. Tabelecleucel is produced from T cells harvested from human donors. Each Ebvallo lot is tested for specificity of lysis of EBV+ targets, T-cell HLA restriction of specific lysis and verification of low alloreactivity. An Ebvallo lot is selected for each patient from the existing product inventory based on an appropriate HLA restriction. 2. Each vial contains 1 mL deliverable volume of Ebvallo at a concentration of 2.8 × 107 – 7.3 × 107 viable T cells/mL dispersion for injection. The quantitative information regarding actual concentration, HLA profile and patient dose calculation is provided in the Lot Information Sheet (LIS) included with the shipper used to transport the medicinal product. The total number of vials in each carton (between 1 vial and 6 vials) corresponds to the dosing requirement for each individual patient, depending on the patient’s body weight (see sections 4.2 and 6.5). Excipient(s) with known effect This medicinal product contains 100 mg dimethyl sulfoxide (DMSO) per mL. For the full list of excipients, see section 6.1. | Dispersion for injection A translucent, colourless to slightly yellow cell dispersion. | Atara Biotherapeutics Ireland Ltd 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland | PLGB 52297/0001 | May 22, 2023 | May 22, 2023 | See Details |
| 559 | AYVAKYT 100 mg film-coated tablets | Each film-coated tablet contains 100 mg of avapritinib. For the full list of excipients, see section 6.1. | Film-coated tablet. Round, white film-coated tablet of 9 mm diameter, printed with blue ink “BLU” on one side and “100” on the other. | Blueprint Medicines (Netherlands) B.V. Gustav Mahlerplein 2 1082 MA Amsterdam Netherlands | PLGB 52115/0001 | Aug. 28, 2025 | Aug. 28, 2025 | See Details |
| 558 | Ciprofloxacin 250 mg film-coated tablets | Each film-coated tablet contains 250 mg ciprofloxacin (as hydrochloride). For the full list of excipients, see section 6.1. | Film-coated tablet. Pink, capsule-shaped film-coated tablets, scored on both sides. The dimension of the tablet is approximately 13.5 mm x 6.5mm. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. | ZMC UK CO., LTD 5 Millmead, Guildford, Surrey, GU2 4BE United Kingdom | PLGB 51923/0011 | May 31, 2022 | Jan. 9, 2024 | See Details |
| 557 | Levofloxacin 500 mg film-coated tablets | Each film-coated tablet contains 500 mg of levofloxacin as levofloxacin hemihydrate. For the full list of excipients, see section 6.1. | Film-coated tablet. Green film-coated tablets, capsular-shaped and scored on both sides. The tablets can be divided into equal doses. | ZMC UK CO., LTD. 5 Millmead, Guildford, Surrey GU2 4BE United Kingdom | PLGB 51923/0010 | May 26, 2022 | Sept. 2, 2025 | See Details |
| 556 | Osenvelt 120 mg solution for injection | Each vial contains 120 mg of denosumab in 1.7 mL of solution (70 mg/mL). Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (Chinese hamster ovary cells) by recombinant DNA technology. Excipients with known effects Each 1.7 mL of solution contains 79.9 mg sorbitol (E420) which is equivalent to 47 mg/mL and 0.17 mg polysorbate 20 (E432) which is equivalent to 0.1 mg/mL. For the full list of excipients, see section 6.1. | Solution for injection (injection). Clear, colourless to pale yellow solution with pH of 5.2. | Celltrion Healthcare United Kingdom Limited The Charter Building, Charter Place, Uxbridge, UB8 1JG United Kingdom | PLGB 51808/0037 | May 29, 2025 | Nov. 4, 2025 | See Details |
| 555 | VEGZELMA 25 mg/mL concentrate for solution for infusion | Each mL of concentrate contains 25 mg of bevacizumab*. Each 4 mL vial contains 100 mg of bevacizumab. For dilution and other handling recommendations, see section 6.6. *Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells. For the full list of excipients, see section 6.1. | Concentrate for solution for infusion. Clear to slightly opalescent, colourless to pale brown liquid. | Celltrion Healthcare United Kingdom Limited The Charter Building, Charter Place, Uxbridge, UB8 1JG, United Kingdom | PLGB 51808/0011 | Sept. 16, 2022 | Feb. 11, 2025 | See Details |
| 554 | Yuflyma 40 mg solution for injection in pre-filled pen | Yuflyma 40 mg solution for injection in pre-filled pen Each 0.4 ml single dose pre-filled pen contains 40 mg of adalimumab. Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells. For the full list of excipients, see section 6.1. | Solution for injection (injection) Clear to slightly opalescent, colourless to pale brown solution. | Celltrion Healthcare United Kingdom Limited The Charter Building Charter Place Uxbridge UB8 1JG United Kingdom | PLGB 51808/0001 | April 1, 2021 | Feb. 13, 2025 | See Details |
| 553 | AQUMELDI 0.25 mg orodispersible tablets | Each orodispersible tablet contains 0.25 mg of enalapril maleate. For the full list of excipients, see section 6.1. | Orodispersible tablet White, round, biconvex orodispersible tablets, 2 mm in diameter. | Proveca Pharma Limited 2 Dublin Landings North Wall Quay Dublin 1 Ireland | PLGB 51785/0001 | Jan. 16, 2024 | Jan. 16, 2024 | See Details |
| 552 | Lysodren 500 mg tablets | Each tablet contains 500 mg of mitotane. For the full list of excipients, see section 6.1. | Tablet. White, biconvex, round, scored tablets. They are bisected on one side and impressed "BL" over "L1" on the other side. | HRA Pharma Rare Diseases 200 avenue de Paris 92320 CHATILLON France | PLGB 51757/0003 | Oct. 11, 2024 | See Details | |
| 551 | Inbrija 33 mg inhalation powder, hard capsules | Each hard capsule contains 42 mg levodopa. Each delivered dose contains 33 mg levodopa. For the full list of excipients, see section 6.1. | Inhalation powder, hard capsule. White opaque capsules containing white powder, with “A42” printed in black on the cap of the capsule and two black bands printed on the body of the capsule. | Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 | PLGB 51169/0001 | Oct. 13, 2025 | Oct. 13, 2025 | See Details |
| 550 | Yorvipath 168 micrograms/0.56 mL solution for injection in pre filled pen | Yorvipath consists of PTH(1-34) conjugated to a methoxypolyethylene glycol carrier (mPEG) via a Linker. Yorvipath 168 micrograms/0.56 mL solution for injection in pre-filled pen Each pre-filled pen contains palopegteriparatide equivalent to 168 micrograms of PTH(1-34) in 0.56 mL of solvent*. The concentration based on PTH(1-34) is 0.3 mg/mL. Each pre-filled pen delivers doses of 6, 9, or 12 micrograms of PTH(1-34). *The strength indicates the quantity of the PTH(1-34) moiety without consideration of the mPEG-linker. For the full list of excipients, see section 6.1. | Solution for injection (injection) Clear and colourless with a pH of 3.7 - 4.3. | Ascendis Pharma Bone Diseases A/S Tuborg Boulevard 12 DK-2900 Hellerup Denmark | PLGB 51127/0001 | April 23, 2024 | Nov. 27, 2025 | See Details |
| 549 | Senshio 60 mg film-coated tablets | Each film-coated tablet contains 60 mg ospemifene. Excipient with known effect Each film-coated tablet contains 1.82 mg lactose as monohydrate. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Oval biconvex, white to off-white, film-coated tablets of dimensions 12 mm x 6.45 mm, debossed with “60” on one side. | Shionogi B.V. Herengracht 464 1017 CA Amsterdam Netherlands | PLGB 50999/0001 | June 15, 2023 | See Details | |
| 548 | Veltassa 1 g powder for oral suspension | Each sachet contains 1 g patiromer (as patiromer sorbitex calcium). For the full list of excipients, see section 6.1. | Powder for oral suspension. Off white to light brown powder, with occasional white particles. | Vifor Fresenius Medical Care Renal Pharma France 100–101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris La Défense Cedex France | PLGB 50784/0010 | June 7, 2024 | Nov. 11, 2024 | See Details |
| 547 | Velphoro 500 mg chewable tablets | Each chewable tablet contains sucroferric oxyhydroxide corresponding to 500 mg iron. The sucroferric oxyhydroxide contained in one tablet is comprised of polynuclear iron (III)- oxyhydroxide (containing 500 mg iron), 750 mg sucrose and 700 mg starches (potato starch and pregelatinised maize starch). For the full list of excipients, see section 6.1. | Chewable tablet. Brown, circular tablets embossed with PA500 on one side. Tablets have a 20 mm diameter and a thickness of 6.5 mm. | Vifor Fresenius Medical Care Renal Pharma France 100–101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex France | PLGB 50784/0001 | Jan. 1, 2021 | Sept. 20, 2022 | See Details |
| 546 | Mysimba 8 mg/90 mg prolonged-release tablets | Each tablet contains 8 mg naltrexone hydrochloride, equivalent to 7.2 mg of naltrexone, and 90 mg bupropion hydrochloride, equivalent to 78 mg of bupropion. Excipient with known effect: Each prolonged-release tablet contains 73.2 mg of lactose (see section 4.4). For the full list of excipients, see section 6.1. | Prolonged-release tablet. Blue, biconvex, round tablet of 12-12.2 mm diameter debossed with “NB-890” on one side. | Orexigen Therapeutics Ireland Limited 9-10 Fenian Street, Dublin 2, D02 RX24 Ireland | PLGB 50742/0001 | Jan. 1, 2021 | Sept. 12, 2025 | See Details |
| 545 | LIVDELZI 10 mg capsules | Each capsule contains seladelpar lysine dihydrate equivalent to 10 mg seladelpar. For the full list of excipients, see section 6.1. | Capsules. Size 1 capsules with dark blue opaque cap and light grey opaque body imprinted with “CBAY” in white ink on the cap and “10” in black ink on the body. | Cymabay Ireland, Limited IDA Business & Technology Park Carrigtohill Cork Ireland T45 DP77 | PLGB 50729/0001 | Jan. 16, 2025 | Jan. 16, 2025 | See Details |
| 544 | NeuroBloc 5000 U/ml solution for injection. | Each ml contains 5000 U Botulinum Toxin Type B. Each 0.5 ml vial contains 2500 U Botulinum Toxin Type B. Each 1.0 ml vial contains 5000 U Botulinum Toxin Type B. Each 2.0 ml vial contains 10,000 U Botulinum Toxin Type B. Produced in Clostridium botulinum Serotype B (Bean Strain) cells. For the full list of excipients, see section 6.1. | Solution for injection. Clear and colourless to light yellow solution. | Sloan Pharma S.à.r.l. 33, Rue du Puits Romain 8070 Bertrange Luxembourg | PLGB 50702/0001 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 543 | ABILIFY 1 mg/mL oral solution | Each mL oral solution contains 1 mg of aripiprazole. Excipients with known effect (per mL) 200 mg fructose, 400 mg sucrose, 1.8 mg methyl parahydroxybenzoate (E218), 0.2 mg propyl parahydroxybenzoate (E 216) For the full list of excipients, see section 6.1. | Oral solution Clear, colourless to light yellow liquid solution. | Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292 1101 CT, Amsterdam Netherlands | PLGB 50697/0001 | Jan. 1, 2021 | Jan. 3, 2023 | See Details |
| 542 | Kigabeq 100 mg soluble tablets | Kigabeq 100 mg soluble tablets Each soluble tablet contains 100 mg vigabatrin. For the full list of excipients, see section 6.1 | Soluble tablet White oval tablets. The tablets are scored on one side and can be divided into equal doses. - 100 mg tablet size: 9.4 mm x 5.3 mm | ORPHELIA Pharma SAS 85 boulevard Saint-Michel 75005 PARIS France | PLGB 50695/0001 | Jan. 1, 2021 | April 11, 2022 | See Details |
| 541 | AMGLIDIA 0.6 mg/mL oral suspension | AMGLIDIA 0.6 mg/mL oral suspension Each mL contains 0.6 mg glibenclamide. Excipient(s) with known effect Each mL contains 2.8 mg of sodium and 5 mg of benzoate salt. For the full list of excipients, see section 6.1. | Oral suspension. White suspension. | AMMTeK 8 rue Campagne Première 75014 Paris Fra nce Tel: + 33 (0)6 74 29 38 14 Distributed by: Bioprojet UK Limited, Unit B, Stanley Court, 3 Glenmore Business Park, Telford Road, Salisbury SP2 7GH, United Kingdom | PLGB 50687/0001 | Nov. 19, 2024 | Jan. 20, 2025 | See Details |
| 540 | Efmody 5 mg modified release hard capsules | Efmody 5 mg modified release hard capsules. Each modified release hard capsule contains 5 mg hydrocortisone. For the full list of excipients, see section 6.1. | Modified release hard capsules. Efmody 5 mg modified release hard capsules. A capsule (approx.19 mm long) with an opaque blue cap and opaque white body printed with “CHC 5 mg” containing white to off white granules. | Neurocrine Netherlands B.V. Van Heuven Goedhartlaan 935 A 1181 LD Amstelveen The Netherlands | PLGB 50616/0011 | July 1, 2021 | Jan. 31, 2025 | See Details |
| 539 | Alkindi 5 mg granules in capsules for opening | Alkindi 5 mg granules in capsules for opening Each capsule contains 5 mg hydrocortisone. For the full list of excipients, see section 6.1. | Granules in capsules for opening. The granules are white to off-white and contained in a transparent colourless (size 00el) hard capsule. Alkindi 5 mg granules in capsules for opening The capsule is printed with "INF-5.0" in grey ink. | Neurocrine Netherlands B.V. Van Heuven Goedhartlaan 935 A 1181 LD Amstelveen The Netherlands | PLGB 50616/0010 | Nov. 21, 2024 | See Details | |
| 538 | Alymsys 25 mg/mL concentrate for solution for infusion. | Each mL of concentrate contains 25 mg of bevacizumab*. Each 4 mL vial contains 100 mg of bevacizumab. Each 16 mL vial contains 400 mg of bevacizumab. For dilution and other handling recommendations, see section 6.6. *Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells. For the full list of excipients, see section 6.1. | Concentrate for solution for infusion (sterile concentrate). Colourless to yellowish or brownish liquid with opalescence, with a pH of 6.0 - 6.3 and an osmolality of 266 - 304 mOsmol/kg. SUMMARY OF PRODUCT CHARACTERISTICS | Mabxience Research SL C/ Manuel Pombo Angulo 28 28050 Madrid Spain | PLGB 48648/0001 | June 3, 2024 | See Details | |
| 537 | Foclivia suspension for injection Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) | Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Vietnam/1194/2004 (H5N1) 7.5 micrograms** per 0.5 ml dose * propagated in fertilised hens’ eggs from healthy chicken flocks ** expressed in micrograms haemagglutinin. Adjuvant MF59C.1 containing: Squalene 9.75 milligrams Polysorbate 80 1.175 milligrams Sorbitan trioleate 1.175 milligrams Sodium citrate 0.66 milligrams Citric acid 0.04 milligrams This vaccine complies with the WHO recommendations and EU decision for the pandemic. Foclivia may contain trace residues of egg and chicken proteins, ovalbumin, kanamycin sulphate, neomycin sulphate, formaldehyde, hydrocortisone and cetyltrimethylammonium bromide which are used during the manufacturing process (see section 4.3). For the full list of excipients, see section 6.1. | Suspension for injection. Milky-white liquid. | Seqirus UK Ltd Point, 29 Market Street Maidenhead SL6 8AA UK | PLGB 47991/0010 | Jan. 1, 2021 | Sept. 13, 2023 | See Details |
| 536 | Skytrofa 3 mg powder and solvent for solution for injection in cartridge Skytrofa 3.6 mg powder and solvent for solution for injection in cartridge Skytrofa 4.3 mg powder and solvent for solution for injection in cartridge Skytrofa 5.2 mg powder and solvent for solution for injection in cartridge Skytrofa 6.3 mg powder and solvent for solution for injection in cartridge Skytrofa 7.6 mg powder and solvent for solution for injection in cartridge Skytrofa 9.1 mg powder and solvent for solution for injection in cartridge Skytrofa 11 mg powder and solvent for solution for injection in cartridge Skytrofa 13.3 mg powder and solvent for solution for injection in cartridge | Lonapegsomatropin Ascendis Pharma consists of somatropin transiently conjugated to a methoxypolyethylene glycol carrier (mPEG) via a proprietary TransCon Linker. The strength of Lonapegsomatropin Ascendis Pharma always indicates the quantity of the somatropin moiety. Each dual-chamber cartridge contains 3 mg of somatropin* equivalent to 8.6 mg of lonapegsomatropin and 0.279 mL of solvent. After reconstitution the concentration based on somatropin** protein is 11 mg/mL. * The strength indicates the quantity of the somatropin moiety without consideration of the mPEG-linker. ** Produced in Escherichia coli cells by recombinant DNA technology. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection (injection). White to off-white powder. The solvent is a clear and colourless solution. | Ascendis Pharma Endocrinology Division A/S Tuborg Boulevard 12 DK-2900 Hellerup Denmark | PLGB 47497/0001 | Oct. 17, 2022 | Dec. 24, 2025 | See Details |
| 535 | ARIKAYCE liposomal 590 mg nebuliser dispersion | Each vial contains amikacin sulfate equivalent to 590 mg amikacin in a liposomal formulation. The mean delivered dose per vial is approximately 312 mg of amikacin. For the full list of excipients, see section 6.1. | Nebuliser dispersion White, milky, aqueous, nebuliser dispersion. | Insmed Netherlands B.V. Stadsplateau 7 3521 AZ Utrecht Netherlands | PLGB 47434/0001 | July 23, 2025 | Nov. 12, 2025 | See Details |
| 534 | Helicobacter Test INFAI for children of the age 3-11 45 mg powder for oral solution | One jar contains 45 mg of 13C-urea powder. For the full list of excipients, see section 6.1. | White, crystalline powder for oral solution. | Infai U.K. Ltd. Innovation Centre Science Park, Innovation Way Heslington YORK YO10 5DG United Kingdom | PLGB 46931/0001 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 533 | Pepaxti 20 mg powder for concentrate for solution for infusion | One vial of powder contains 20 mg melphalan flufenamide (as hydrochloride). For the full list of excipients, see section 6.1. | Powder for concentrate for solution for infusion (powder for concentrate). Lyophilised white to off-white powder. | Oncopeptides AB (publ) Luntmakargatan 46 111 37 Stockholm Sweden | PLGB 46117/0001 | Nov. 11, 2022 | Jan. 30, 2025 | See Details |
| 532 | Aucatzyl 410 × 106 cells dispersion for infusion | 2.1 General description Aucatzyl (obecabtagene autoleucel) is a genetically modified autologous T cell immunotherapy containing T cells transduced ex vivo using a lentiviral vector expressing an anti-CD19 chimeric antigen receptor (CAR), comprising a murine anti- CD19 single chain variable fragment linked to a 4-1BB co-stimulatory domain and a CD3-zeta signalling domain. 2. Each patient-specific infusion bag of Aucatzyl contains obecabtagene autoleucel at a target concentration of 10 × 106 total viable cells/mL of autologous T cells genetically modified to express an anti-CD19 chimeric antigen receptor (CAR positive viable T cells). The medicinal product is packaged in three or more infusion bags overall containing a cell dispersion for infusion of a target dose of 410 × 106 CAR-positive viable T cells suspended in a cryopreservative solution. Each infusion bag contains 10-20 mL or 30-70 mL of dispersion for infusion. The quantitative information of medicinal product, including the number of infusion bags (see section 6) to be administered, is presented in the Release for Infusion Certificate provided via the Autolus Scheduling Portal and located inside the lid of the vapour phase of a liquid nitrogen shipper used for transporting the medicinal product. Excipient(s) with known effect This medicinal product contains 7.5% dimethyl sulfoxide, and up to 1131 mg sodium and 39 mg potassium per total dose (see section 4.4). For the full list of excipients, see section 6.1. | Dispersion for infusion. Colourless to pale yellow, very opalescent dispersion. | Autolus Limited The Mediaworks 191 Wood Lane White City London W12 7FP | PLGB 46113/0001 | Jan. 20, 2026 | Jan. 20, 2026 | See Details |
| 531 | Dukoral suspension and effervescent powder for oral suspension Cholera vaccine (inactivated, oral) | Each dose of vaccine suspension (3 ml) contains: - A total of 1.25x1011 bacteria of the following strains: Vibrio cholerae O1 Inaba, classical biotype (heat inactivated) 31.25x109 bacteria* Vibrio cholerae O1 Inaba, El Tor biotype (formalin inactivated) 31.25x109 bacteria* Vibrio cholerae O1 Ogawa, classical biotype (heat inactivated) 31.25x109 bacteria* Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 31.25x109 bacteria* Recombinant cholera toxin B subunit (rCTB) 1 mg (produced in V. cholerae O1 Inaba, classical biotype strain 213.) * Bacterial count before inactivation. Excipients: Sodium dihydrogen phosphate dihydrate 2.0 mg, disodium hydrogen phosphate dihydrate 9.4 mg, sodium chloride 26 mg, sodium hydrogen carbonate 3600 mg, sodium carbonate anhydrous 400 mg, saccharin sodium 30 mg, sodium citrate 6 mg. One dose contains approximately 1.1 g sodium. For a full list of excipients, see section 6.1. | Suspension and effervescent powder for oral suspension: - Suspension for oral suspension - Powder for oral suspension in a sachet. | Valneva Sweden AB S-105 21 Stockholm Sweden +46 (0)8 735 1000 infodukoral@valneva.com | PLGB 46066/0001 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 530 | Nityr 10 mg tablets | Each tablet contains 10 mg nitisinone. Excipient with known effect Each tablet contains 102.99 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. | Tablet. White to beige, round (7 mm), flat tablets which may display light yellow to brown speckles, marked “10” on one side and “L” on the other side. | Cycle Pharmaceuticals Ltd The Broers Building, 21 JJ Thomson Avenue, Cambridge, CB3 0FA United Kingdom | PLGB 45886/0001 | May 4, 2023 | Oct. 3, 2024 | See Details |
| 529 | Xbryk 120 mg solution for injection | Each vial contains 120 mg of denosumab in 1.7 mL of solution (70 mg/mL). Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (Chinese hamster ovary cells) by recombinant DNA technology. Excipient with known effects Each 1.7 mL of solution contains 74.8 mg sorbitol. For the full list of excipients, see section 6.1. | Solution for injection (injection). Clear, colourless to slightly yellow solution and may contain trace amounts of translucent to white proteinaceous particles. | Samsung Bioepis UK Limited 5th floor Profile West 950 Great West Road Brentford Middlesex TW8 9ES United Kingdom | PLGB 45613/0023 | March 27, 2025 | Aug. 6, 2025 | See Details |
| 528 | Imraldi 40 mg/0.8 ml solution for injection | Each 0.8 ml single dose vial contains 40 mg of adalimumab. Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells. Excipient(s) with known effect This medicinal product contains 20.0 mg sorbitol. For the full list of excipients, see section 6.1. | Solution for injection (injection). Clear to opalescent, colourless to pale brown solution. | Samsung Bioepis UK Limited 5th floor, Profile West, 950 Great West Road Brentford, Middlesex TW8 9ES United Kingdom | PLGB 45613/0011 | Feb. 17, 2025 | See Details | |
| 527 | Chenodeoxycholic acid Leadiant 250 mg hard capsules | Each hard capsule contains 250 mg of chenodeoxycholic acid. For the full list of excipients, see section 6.1. | Hard capsule Size 0 capsule, 21.7 mm in length with a yellow body and orange cap, containing a white, compressed powder. | Leadiant Biosciences Ltd. 21 Holborn Viaduct London EC1A 2DY United Kingdom | PLGB 44975/0001 | Jan. 22, 2026 | See Details | |
| 526 | Axumin 1,600 MBq/mL solution for injection | Axumin 1,600 MBq/mL solution for injection Each mL of solution contains 1,600 MBq of fluciclovine (18F) at the date and time of calibration (ToC). The activity per vial ranges from 1,600 MBq to 16,000 MBq at the date and ToC. Fluorine (18F) decays to stable oxygen (18O) with a half-life of 110 minutes by emitting a positronic radiation of maximum energy of 634 keV, followed by photonic annihilation radiations of 511 keV. Excipients with known effect Each mL of solution contains 7.7 mg of sodium. For the full list of excipients, see section 6.1. | Solution for injection. Clear, colourless solution. | Blue Earth Diagnostics Ltd The Oxford Science Park Magdalen Centre, Robert Robinson Avenue Oxford OX4 4GA | PLGB 44578/0001 | Nov. 4, 2022 | Nov. 4, 2022 | See Details |
| 525 | Pylclari 1 500 MBq/mL solution for injection | Pylclari 1 500 MBq/mL solution for injection Each ml of solution contains 1 500 MBq of piflufolastat (18F) at the date and time of calibration. The total activity per vial ranges from 750 MBq to 15 000 MBq at the date and time of calibration. Fluorine (18F) decays to stable oxygen (18O) with a half-life of 110 minutes by emitting a positronic radiation of maximum energy of 634 keV, followed by photonic annihilation radiations of 511 keV. Excipient(s) with known effect Each ml of solution contains a maximum of 3.5 mg of sodium and 90 mg of ethanol. For the full list of excipients, see section 6.1. | Solution for injection. Clear, colourless solution with a pH ranging from 4.5 to 7.5. | Curium Pharma UK Ltd Suite 211b Central Second Floor, Building 1000 Lakeside North Harbour Portsmouth PO6 3EN United Kingdom | PLGB 44301/0004 | March 6, 2024 | See Details | |
| 524 | Pylclari 1 000 MBq/mL solution for injection | Pylclari 1 000 MBq/mL solution for injection Each ml of solution contains 1 000 MBq of piflufolastat (18F) at the date and time of calibration. The total activity per vial ranges from 500 MBq to 10 000 MBq at the date and time of calibration. Fluorine (18F) decays to stable oxygen (18O) with a half-life of 110 minutes by emitting a positronic radiation of maximum energy of 634 keV, followed by photonic annihilation radiations of 511 keV. Excipient(s) with known effect Each ml of solution contains a maximum of 3.5 mg of sodium and 90 mg of ethanol. For the full list of excipients, see section 6.1. | Solution for injection. Clear, colourless solution with a pH ranging from 4.5 to 7.5. | Curium Pharma UK Ltd Suite 211b Central Second Floor, Building 1000 Lakeside North Harbour Portsmouth PO6 3EN United Kingdom | PLGB 44301/0003 | March 6, 2024 | See Details | |
| 523 | InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix | One vial contains 4 mg (4 mg pack) or 12 mg (12 mg pack) dibotermin alfa. After reconstitution, InductOs contains 1.5 mg/ml dibotermin alfa. Dibotermin alfa (recombinant human Bone Morphogenetic Protein-2; rhBMP-2) is a human protein derived from a recombinant Chinese Hamster Ovary (CHO) cell line. For the full list of excipients, see section 6.1. | Powder, solvent and matrix for implantation matrix. The powder is white. The solvent is a clear colourless liquid. The matrix is white. | Medtronic BioPharma B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands tel +31 (0) 45 566 8000 fax +31 (0) 45 566 8012 | PLGB 43872/0001 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 522 | HETLIOZ 20 mg hard capsules | Each hard capsule contains 20 mg tasimelteon. Excipients with known effect Each hard capsule contains 183.25 mg of lactose (as anhydrous) and 0.03 mg of Orange Yellow S (E110). For the full list of excipients, see section 6.1. | Hard capsule Dark blue opaque, hard capsule (dimensions 19.4 mm x 6.9 mm) marked with ‘VANDA 20 mg’ in white ink. | Vanda Pharmaceuticals Netherlands B.V. Prins Bernhardplein 200 1097 JB Amsterdam The Netherlands | PLGB 43460/0001 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 521 | Ponvory 2 mg film-coated tablets Ponvory 3 mg film-coated tablets Ponvory 4 mg film-coated tablets Ponvory 5 mg film-coated tablets Ponvory 6 mg film-coated tablets Ponvory 7 mg film-coated tablets Ponvory 8 mg film-coated tablets Ponvory 9 mg film-coated tablets Ponvory 10 mg film-coated tablets | Ponvory 2 mg film-coated tablets Each film-coated tablet contains 2 mg of ponesimod Excipient with known effect Each tablet contains 23 mg of lactose. Ponvory 3 mg film-coated tablets Each film-coated tablet contains 3 mg of ponesimod Excipient with known effect Each tablet contains 22 mg of lactose. Ponvory 4 mg film-coated tablets Each film-coated tablet contains 4 mg of ponesimod Excipient with known effect Each tablet contains 21 mg of lactose. Ponvory 5 mg film-coated tablets Each film-coated tablet contains 5 mg of ponesimod Excipient with known effect Each tablet contains 118 mg of lactose. Ponvory 6 mg film-coated tablets Each film-coated tablet contains 6 mg of ponesimod Excipient with known effect Each tablet contains 117 mg of lactose. Ponvory 7 mg film-coated tablets Each film-coated tablet contains 7 mg of ponesimod Excipient with known effect Each tablet contains 117 mg of lactose. Ponvory 8 mg film-coated tablets Each film-coated tablet contains 8 mg of ponesimod Excipient with known effect Each tablet contains 116 mg of lactose. Ponvory 9 mg film-coated tablets Each film-coated tablet contains 9 mg of ponesimod Excipient with known effect Each tablet contains 115 mg of lactose. Ponvory 10 mg film-coated tablets Each film-coated tablet contains 10 mg of ponesimod Excipient with known effect Each tablet contains 114 mg of lactose. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet) Ponvory 2 mg film-coated tablets White, round, biconvex, film-coated tablet of 5 mm diameter with “2” on one side and an arch on the other side. Ponvory 3 mg film-coated tablets Red, round, biconvex, film-coated tablet of 5 mm diameter with “3” on one side and an arch on the other side. Ponvory 4 mg film-coated tablets Purple, round, biconvex, film-coated tablet of 5 mm diameter with “4” on one side and an arch on the other side. Ponvory 5 mg film-coated tablets Green, round, biconvex, film-coated tablet of 8.6 mm diameter with “5” on one side and an arch and an “A” on the other side. Ponvory 6 mg film-coated tablets White, round, biconvex, film-coated tablet of 8.6 mm diameter with “6” on one side and an arch and an “A” on the other side. Ponvory 7 mg film-coated tablets Red, round, biconvex, film-coated tablet of 8.6 mm diameter with “7” on one side and an arch and an “A” on the other side. Ponvory 8 mg film-coated tablets Purple, round, biconvex, film-coated tablet of 8.6 mm diameter with “8” on one side and an arch and an “A” on the other side. Ponvory 9 mg film-coated tablets Brown, round, biconvex, film-coated tablet of 8.6 mm diameter with “9” on one side and an arch and an “A” on the other side. Ponvory 10 mg film-coated tablets Orange, round, biconvex, film-coated tablet of 8.6 mm diameter with “10” on one side and an arch and an “A” on the other side. | Laboratoires Juvise Pharmaceuticals 149 Boulevard Bataille de Stalingrad 69100 Villeurbanne France | PLGB 43311/0001 | July 29, 2021 | Jan. 22, 2026 | See Details |
| 520 | IXIARO suspension for injection Japanese encephalitis vaccine (inactivated, adsorbed) | 1 dose (0.5 ml) of IXIARO contains: Japanese encephalitis virus strain SA14-14-2 (inactivated)1,2 6 AU3 corresponding to a potency of = 460 ng ED50 1 produced in Vero cells 2 adsorbed on aluminium hydroxide, hydrated (approximately 0.25 milligrams Al3+) 3 Antigen Units Excipients with known effect: This medicine contains potassium, less than 1mmol (39 mg) per 0.5 ml single dosage i.e. essentially ‘potassium-free’ and less than 1 mmol sodium (23 mg) per 0.5 ml single dosage, that is to say essentially ‘sodium-free’. This product might contain traces of residual sodium metabisulfite which is below detection limit. Phosphate Buffered Saline 0.0067 M (in PO4) has the following saline composition: NaCl – 9mg/mL KH2PO4 – 0.144 mg/mL Na2HPO4 – 0.795 mg/mL For the full list of excipients, see section 6.1. | Suspension for injection. Clear liquid with a white precipitate. | Valneva Austria GmbH Campus Vienna Biocenter 3 A-1030 Vienna Austria | PLGB 43185/0001 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 519 | Buvidal 8 mg prolonged-release solution for injection | 8 mg prolonged-release solution for injection Each pre-filled syringe contains 8 mg buprenorphine Excipient(s) with known effect The 8 mg, 16 mg, 24 mg and 32 mg strengths contain 95.7 mg of alcohol (ethanol) in each mL (10% w/w). For the full list of excipients, see section 6.1. | Prolonged-release solution for injection. Yellowish to yellow clear liquid. | Camurus AB Rydbergs torg 4 SE-224 84 Lund Sweden | PLGB 42800/0001 | March 19, 2024 | April 10, 2025 | See Details |
| 518 | Pemazyre 13.5 mg tablets | Pemazyre 13.5 mg tablets Each tablet contains 13.5 mg of pemigatinib. For the full list of excipients, see section 6.1. | Tablet. Pemazyre 13.5 mg tablets Round (8.5 mm), white to off-white tablet debossed on one side with "I" and "13.5" on the reverse. | Incyte Biosciences UK Ltd First Floor Q1, The Square Randalls Way, Leatherhead KT22 7TW, UK | PLGB 42338/0010 | Jan. 20, 2026 | Jan. 20, 2026 | See Details |
| 517 | Jyseleca 100 mg film-coated tablets | Jyseleca 100 mg film-coated tablets Each film-coated tablet contains filgotinib maleate equivalent to 100 mg of filgotinib. Excipient with known effect Each 100 mg film-coated tablet contains 76 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. | Film-coated tablet. Jyseleca 100 mg film-coated tablets Beige 12 × 7 mm, capsule-shaped, film-coated tablet debossed with “G” on one side and “100” on the other side. | Galapagos NV Generaal De Wittelaan L11 A3 2800 Mechelen Belgium | PLGB 42147/0001 | Jan. 1, 2021 | July 1, 2024 | See Details |
| 516 | Lytgobi 4 mg film-coated tablets | Each film-coated tablet contains 4 mg of futibatinib. Excipient with known effect Each film-coated tablet contains 5.4 mg lactose monohydrate. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Round (6 mm), white, film-coated tablet debossed on one side with “4MG” and “FBN” on the reverse. | Taiho Pharma Europe Limited Building 2, Croxley Business Park, Watford Hertfordshire, WD18 8YA United Kingdom | PLGB 41225/0001 | July 8, 2025 | Dec. 16, 2025 | See Details |
| 515 | KIMMTRAK 200 micrograms/ mL concentrate for solution for infusion | One 0.5 mL vial contains 100 micrograms of tebentafusp, corresponding to a concentration before dilution of 200 mcg/mL Tebentafusp is a bispecific gp100-targeted T cell receptor fusion protein with an approximate molecular weight of 77 kDa. Tebentafusp is produced by recombinant DNA technology in Escherichia coli cells. For the full list of excipients, see section 6.1. | Concentrate for solution for infusion (sterile concentrate) Clear, colourless to slightly yellowish solution in a single-dose vial. | Immunocore Limited 92 Park Drive Abingdon, Oxfordshire OX14 4RY United Kingdom | PLGB 36781/0001 | June 7, 2022 | June 7, 2022 | See Details |
| 514 | Epidyolex 100 mg/ml oral solution | Each ml of oral solution contains 100 mg cannabidiol. Excipients with known effect Each ml of solution contains: 79 mg anhydrous ethanol 736 mg refined sesame oil 0.0003 mg benzyl alcohol For the full list of excipients, see section 6.1. | Oral solution Clear, colourless to yellow solution | Jazz Pharmaceuticals Research UK Limited Building 730, Kent Science Park, Sittingbourne, Kent ME9 8AG, United Kingdom e-mail: medinfo-uk@jazzpharma.com | PLGB 36772/0001 | Jan. 1, 2021 | Jan. 10, 2025 | See Details |
| 513 | Suboxone 2 mg/0.5 mg sublingual tablets | Suboxone 2 mg/0.5 mg sublingual tablets Each sublingual tablet contains 2 mg buprenorphine (as hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate). Excipients with known effect: Each sublingual tablet contains 42 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. | Sublingual tablet Suboxone 2 mg/0.5 mg sublingual tablets White hexagonal biconvex tablets of 6.5 mm with “N2” debossed on one side. | Indivior UK Limited The Chapleo Building Henry Boot Way Priory Park Hull HU4 7DY United Kingdom | PLGB 36699/0011 | Jan. 1, 2021 | Jan. 20, 2025 | See Details |
| 512 | Suboxone 16 mg/4 mg sublingual tablets | Suboxone 16 mg/4 mg sublingual tablets Each sublingual tablet contains 16 mg buprenorphine (as hydrochloride) and 4 mg naloxone (as hydrochloride dihydrate). Excipients with known effect: Each sublingual tablet contains 156.64 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. | Sublingual tablet Suboxone 16 mg/4 mg sublingual tablets White round biconvex tablets of 10.5 mm with “N16” debossed on one side. | Indivior UK Limited The Chapleo Building Henry Boot Way Priory Park Hull HU4 7DY United Kingdom | PLGB 36699/0010 | Jan. 1, 2021 | Jan. 20, 2025 | See Details |
| 511 | TOOKAD 183 mg powder for solution for injection | TOOKAD 183 mg powder for solution for injection Each vial contains 183 mg of padeliporfin (as di-potassium salt). 1 mL of reconstituted solution contains 9.15 mg of padeliporfin. For the full list of excipients, see section 6.1. | Powder for solution for injection. The powder is a dark lyophilisate. | Steba Biotech S.A. 7 Place du Théâtre L-2613 Luxembourg Luxembourg | PLGB 34903/0001 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 510 | Joenja 70 mg film-coated tablets | Each film-coated tablet contains leniolisib phosphate equivalent to 70 mg leniolisib. Excipient with known effect Each film-coated tablet contains 241.16 mg of lactose monohydrate. For the full list of excipients, see section 6.1. | Film-coated tablet. Yellow, oval-shaped, biconvex, bevelled edge film-coated tablet debossed with “70” on one side and “LNB” on the other side. | Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands | PLGB 33010/0001 | Sept. 25, 2024 | Aug. 27, 2025 | See Details |
| 509 | Xadago 100 mg film-coated tablets | Each film-coated tablet contains safinamide methansulfonate equivalent to 100 mg safinamide. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet) Orange to copper, round, biconcave, film-coated tablet of 9 mm diameter with metallic gloss, embossed with the strength “100” on one side of the tablet. | Zambon S.p.A. Via Lillo del Duca 10 20091 Bresso (MI) - Italy Tel: +39 02 665241 Fax: +39 02 66501492 Email: info.zambonspa@zambongroup.com | PLGB 31654/0011 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 508 | ELOCTA 1000 IU powder and solvent for solution for injection | Each vial contains nominally 1000 IU efmoroctocog alfa. ELOCTA contains approximately 333 IU/mL of recombinant efmoroctocog alfa after reconstitution. The potency (International Units (IU)) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of ELOCTA is 4000- 10200 IU/mg protein. Efmoroctocog alfa (recombinant human coagulation factor VIII, Fc fusion protein (rFVIIIFc)) has 1,890 amino acids. It is produced by recombinant DNA technology in a human embryonic kidney (HEK) cell line without the addition of any exogenous human- or animal-derived protein in the cell culture process, purification or final formulation. Excipient with known effect 0.6 mmol (or 14 mg) sodium per vial. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. Powder: lyophilised, white to off-white powder or cake. Solvent: water for injections, a clear, colourless solution. Formatted: Left: 3.17 cm, Right: 3.17 cm, Top: 2.54 cm, Bottom: 2.54 cm, Width: 21 cm, Height: 29.7 cm | Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm Sweden | PLGB 30941/0011 | Jan. 1, 2021 | Aug. 21, 2024 | See Details |
| 507 | ELOCTA 750 IU powder and solvent for solution for injection | Each vial contains nominally 750 IU efmoroctocog alfa. ELOCTA contains approximately 250 IU/mL of recombinant efmoroctocog alfa after reconstitution. The potency (International Units (IU)) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of ELOCTA is 4000- 10200 IU/mg protein. Efmoroctocog alfa (recombinant human coagulation factor VIII, Fc fusion protein (rFVIIIFc)) has 1,890 amino acids. It is produced by recombinant DNA technology in a human embryonic kidney (HEK) cell line without the addition of any exogenous human- or animal-derived protein in the cell culture process, purification or final formulation. Excipient with known effect 0.6 mmol (or 14 mg) sodium per vial. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. Powder: lyophilised, white to off-white powder or cake. Solvent: water for injections, a clear, colourless solution. Formatted: Left: 3.17 cm, Right: 3.17 cm, Top: 2.54 cm, Bottom: 2.54 cm, Width: 21 cm, Height: 29.7 cm | Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm Sweden | PLGB 30941/0010 | Jan. 1, 2021 | Aug. 21, 2024 | See Details |
| 506 | Bylvay 600 micrograms hard capsules | Each hard capsule contains odevixibat sesquihydrate equivalent to 600 micrograms odevixibat For the full list of excipients see section 6.1. | Hard capsule Size 0 capsule (21.7 mm × 7.64 mm) with ivory opaque cap and body; imprinted “A600” with black ink. | Ipsen Pharma 70 rue Balard 75015 Paris France | PLGB 28247/0011 | July 21, 2025 | See Details | |
| 505 | Bylvay 400 micrograms hard capsules | Each hard capsule contains odevixibat sesquihydrate equivalent to 400 micrograms odevixibat For the full list of excipients see section 6.1. | Hard capsule Size 3 capsule (15.9 mm × 5.82 mm) with orange opaque cap and white opaque body; imprinted “A400” with black ink. | Ipsen Pharma 70 rue Balard 75015 Paris France | PLGB 28247/0010 | Sept. 7, 2021 | July 21, 2025 | See Details |
| 504 | Cabozantinib Ipsen 20 mg film-coated tablets | Each film-coated tablet contains cabozantinib (S)-malate equivalent to 20 mg cabozantinib. Excipients with known effect Each film-coated tablet contains 15.54 mg lactose. For the full list of excipients, see section 6.1. | Film-coated tablet. The tablets are yellow round with no score and debossed with “XL” on one side and “20” on the other side of the tablet. | Ipsen Pharma 70 rue Balard 75015 Paris France | PLGB 28247/0001 | Nov. 17, 2021 | Sept. 18, 2025 | See Details |
| 503 | Zokinvy 75 mg hard capsules | Each capsule contains 75 mg lonafarnib. For the full list of excipients, see section 6.1. | Hard capsule (capsule) Size 3 hard capsule (6 mm x 16 mm), opaque light orange with “LNF and “75” printed in black. | TMC Pharma Services Limited. Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire, RG27 8AS United Kingdom | PLGB 24576/0012 | Aug. 24, 2022 | Sept. 13, 2024 | See Details |
| 502 | Zokinvy 50 mg hard capsules | Each capsule contains 50 mg lonafarnib. For the full list of excipients, see section 6.1. | Hard capsule (capsule) Size 4 hard capsule (5 mm x 14 mm), opaque yellow with “LNF” and “50” printed in black. | TMC Pharma Services Limited. Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire, RG27 8AS United Kingdom | PLGB 24576/0011 | Aug. 24, 2022 | Sept. 13, 2024 | See Details |
| 501 | LOQTORZI 240 mg concentrate for solution for infusion | One vial of concentrate for solution for infusion contains 240 mg of toripalimab. Each mL of concentrate for solution for infusion contains 40 mg of toripalimab. Toripalimab is an immunoglobulin G4 (IgG4) humanised monoclonal antibody (mAb), produced in Chinese hamster ovary cells by recombinant DNA technology. For the full list of excipients, see section 6.1. | Concentrate for solution for infusion. Clear to slightly opalescent, colourless to slightly yellow solution essentially free from visible particles. The concentrate for solution has a pH of 5.5 – 6.5 and an osmolality of 260-340 mOsmol/kg. | TMC Pharma Services Limited Fleet Road Hartley Wintney Hampshire RG27 8AS United Kingdom | PLGB 24576/0010 | Nov. 15, 2024 | Nov. 15, 2024 | See Details |
| 500 | Verorab, powder and solvent for suspension for injection Rabies vaccine, inactivated | After reconstitution with 0.5 mL solvent, 1 vial contains: Rabies virusa, WISTAR Rabies PM/WI38 1503-3M strain (inactivated)........................3.25 IUb a Produced in Vero cells b Quantity measured according to the ELISA test against the international standard Excipient with known effect: Phenylalanine ..........................................................................................4.1 micrograms For the full list of excipients, see section 6.1. Verorab may contain traces of polymyxin B, streptomycin and neomycin, used in the manufacturing process (see section 4.3). | Powder and solvent for suspension for injection. Before reconstitution, the powder is uniform white in colour. The solvent is a clear, colourless solution. | Sanofi Winthrop Industrie 82 avenue Raspail 94250 Gentilly France Distributed in the UK by: Sanofi 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK | PLGB 23228/0001 | Nov. 1, 2023 | Jan. 29, 2026 | See Details |
| 499 | Tysabri 150 mg solution for injection in pre-filled syringe | Each mL contains 150 mg of natalizumab. Natalizumab is a recombinant humanised anti-a4-integrin antibody produced in a murine cell line by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection (injection) Colourless to slightly yellow, slightly opalescent to opalescent solution. | Biogen Netherlands B.V. Prins Mauritslaan 13 1171 LP Badhoevedorp The Netherlands | PLGB 22407/0011 | Oct. 9, 2025 | Oct. 9, 2025 | See Details |
| 498 | TYSABRI 300 mg concentrate for solution for infusion | Each ml of concentrate contains 20 mg of natalizumab. When diluted (see section 6.6), the solution for infusion contains approximately 2.6 mg/ml of natalizumab. Natalizumab is a recombinant humanised anti-a4-integrin antibody produced in a murine cell line by recombinant DNA technology. Excipient with known effect Each vial contains 2.3 mmol (or 52 mg) sodium. When diluted in 100 ml sodium chloride 9 mg/ml (0.9%) the medicinal product contains 17.7 mmol (or 406 mg) sodium. For the full list of excipients, see section 6.1. | Concentrate for solution for infusion. Colourless, clear to slightly opalescent solution. | Biogen Netherlands BV Prins Mauritslaan 13 Badhoevedorp NL-1171 LP Netherlands | PLGB 22407/0010 | Jan. 1, 2021 | Nov. 8, 2024 | See Details |
| 497 | Kalydeco 75 mg granules in sachet | Each sachet contains 75 mg of ivacaftor. Excipient with known effect Each sachet contains 109.8 mg of lactose monohydrate. For the full list of excipients, see section 6.1. | Granules in sachet White to off-white granules approximately 2 mm in diameter. | Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street London, W2 6BD United Kingdom | PLGB 22352/0011 | April 29, 2022 | Nov. 27, 2023 | See Details |
| 496 | Kalydeco 50 mg granules in sachet | Each sachet contains 50 mg of ivacaftor. Excipient with known effect Each sachet contains 73.2 mg of lactose monohydrate. For the full list of excipients, see section 6.1. | Granules in sachet White to off-white granules approximately 2 mm in diameter. | Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street London, W2 6BD United Kingdom | PLGB 22352/0010 | April 29, 2022 | Nov. 15, 2023 | See Details |
| 495 | Ongentys 50 mg hard capsules | Each hard capsule contains 50 mg of opicapone. Excipient(s) with known effect Each hard capsule contains 148.2 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. | Hard capsule (capsule) Dark blue capsules, size 1, approximately 19 mm, imprinted “OPC 50” on the cap and “Bial” on the body. | Bial - Portela & Cª, S.A. À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal Tel:+351 22 986 61 00 Fax: +351 22 986 61 90 e-mail: info@bial.com | PLGB 21566/0004 | Jan. 1, 2021 | June 24, 2025 | See Details |
| 494 | Senstend 150 mg/ml + 50 mg/ml cutaneous spray, solution | Each ml of solution contains 150 mg lidocaine and 50 mg prilocaine. Each actuation delivers 50 microlitres which contains 7.5 mg lidocaine and 2.5 mg prilocaine. Each container of 6.5 ml delivers a minimum of 20 doses. Each container of 5 ml delivers a minimum of 12 doses. For the full list of excipients, see section 6.1 | Cutaneous spray, solution Colourless to light yellow solution | Plethora Solutions Limited Hampden House Monument Business Park Chalgrove OX44 7RW UK | PLGB 21244/0001 | Nov. 14, 2024 | Dec. 15, 2025 | See Details |
| 493 | Nilotinib 200 mg hard capsules | One hard capsule contains 200 mg nilotinib. Excipient with known effect One hard capsule contains about 160 mg lactose (as monohydrate) and allura red AC. For the full list of excipients, see section 6.1. | Hard capsule. Hard gelatin capsule size “0” (approximately 21 mm in length) with light yellow opaque cap and light yellow opaque body imprinted with red ink “SML” on the cap and “27” on the body containing off white to grey granular powder. | Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex HA1 4HF United Kingdom | PLGB 20075/1531 | Dec. 2, 2024 | Feb. 14, 2025 | See Details |
| 492 | Nilotinib 150 mg hard capsules | One hard capsule contains 150 mg nilotinib. Excipient with known effect One hard capsule contains about 120 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. | Hard capsule. Hard gelatin capsule size “1” (approximately 19 mm in length) with red opaque cap and red opaque body imprinted with black ink “SML” on the cap and “26” on the body containing off white to grey granular powder. | Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex HA1 4HF United Kingdom | PLGB 20075/1530 | Dec. 2, 2024 | Feb. 14, 2025 | See Details |
| 491 | Nilotinib 50 mg hard capsules | One hard capsule contains 50 mg nilotinib. Excipient with known effect One hard capsule contains about 40 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. | Hard capsule. Hard gelatin capsule size “4” (approximately 14 mm in length) with red opaque cap and light yellow opaque body imprinted with black ink “SML” on the cap and “39” on the body containing off white to grey granular powder. | Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex HA1 4HF United Kingdom | PLGB 20075/1529 | Dec. 2, 2024 | Feb. 14, 2025 | See Details |
| 490 | ellaOne 30 mg film-coated tablet | Each tablet contains 30 mg ulipristal acetate. Excipients with known effect Each tablet contains 237 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1 | Film-coated tablet Golden film-coated tablet of shield shape (around 10,8 mm diameter) with “ella” engraved on both sides. | LABORATOIRE HRA PHARMA 200 avenue de Paris 92320 CHATILLON France | PLGB 17836/0011 | Jan. 1, 2021 | Oct. 19, 2022 | See Details |
| 489 | CEVENFACTA 1 mg (45 KIU) powder and solvent for solution for injection | Each vial contains nominally 1 mg eptacog beta (activated) (45 KIU/vial) corresponding to a concentration of approximately 1 mg/mL (45 KIU/mL) when reconstituted with 1.1 mL of water for injections. The potency (IU) is determined using a clotting assay. 1 KIU equals 1 000 IU (International Units). Eptacog beta (activated) is a recombinant coagulation Factor VIIa (rFVIIa) with a molecular mass of approximately 50 000 Daltons produced from rabbit milk by recombinant DNA technology. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection (vial: powder for injection; pre-filled syringe: water for injections). White to off-white lyophilised powder. Solvent: clear and colourless solution. The solution has a pH of approximately 6. The osmolality is approximately 290 mOsm/kg. | Laboratoire français du Fractionnement et des Biotechnologies Tour W 102 Terrasse Boieldieu, 19ème Étage 92800 Puteaux France | PLGB 17469/0011 | Aug. 19, 2022 | Aug. 19, 2022 | See Details |
| 488 | POTELIGEO 4 mg/mL concentrate for solution for infusion. | Each vial contains 20 mg of mogamulizumab in 5 mL, corresponding to 4 mg/mL. Mogamulizumab is produced in Chinese hamster ovary cells by recombinant DNA technology. For the full list of excipients, see section 6.1. | Concentrate for solution for infusion. Clear to slightly opalescent, colourless solution. | Kyowa Kirin Holdings B.V. Bloemlaan 2 2132NP Hoofddorp Netherlands medinfo@kyowakirin.com | PLGB 16508/0074 | Sept. 16, 2025 | See Details | |
| 487 | ADENURIC 120 mg film-coated tablets | Each tablet contains 120 mg of febuxostat. Excipient(s) with known effects: Each tablet contains 114.75 mg of lactose (as monohydrate) For the full list of excipients, see section 6.1. | Film-coated tablet (tablets). Pale yellow to yellow, film-coated, capsule shaped tablets, engraved with “120” on one side. | Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg | PLGB 16239/0050 | Jan. 1, 2021 | July 25, 2023 | See Details |
| 486 | SPRYCEL 80 mg film-coated tablets | SPRYCEL 80 mg film-coated tablets Each film-coated tablet contains 80 mg dasatinib (as monohydrate). Excipient with known effect Each film-coated tablet contains 108 mg of lactose monohydrate. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). SPRYCEL 80 mg film-coated tablets White to off-white, biconvex, triangular film-coated tablet with "BMS 80" debossed on one side and "855" on the other side. | Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland | PLGB 15105/0146 | Jan. 1, 2021 | Oct. 13, 2022 | See Details |
| 485 | SPRYCEL 50 mg film-coated tablets | SPRYCEL 50 mg film-coated tablets Each film-coated tablet contains 50 mg dasatinib (as monohydrate). Excipient with known effect Each film-coated tablet contains 67.5 mg of lactose monohydrate. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). SPRYCEL 50 mg film-coated tablets White to off-white, biconvex, oval film-coated tablet with "BMS" debossed on one side and "528" on the other side. | Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland | PLGB 15105/0145 | Jan. 1, 2021 | Oct. 13, 2022 | See Details |
| 484 | SPRYCEL 20 mg film-coated tablets | SPRYCEL 20 mg film-coated tablets Each film-coated tablet contains 20 mg dasatinib (as monohydrate). Excipient with known effect Each film-coated tablet contains 27 mg of lactose monohydrate. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). SPRYCEL 20 mg film-coated tablets White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "527" on the other side. | Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland | PLGB 15105/0144 | Jan. 1, 2021 | Oct. 13, 2022 | See Details |
| 483 | SPRYCEL 140 mg film-coated tablets | SPRYCEL 140 mg film-coated tablets Each film-coated tablet contains 140 mg dasatinib (as monohydrate). Excipient with known effect Each film-coated tablet contains 189 mg of lactose monohydrate. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). SPRYCEL 140 mg film-coated tablets White to off-white, biconvex, round film-coated tablet with "BMS 140" debossed on one side and "857" on the other side. | Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland | PLGB 15105/0143 | Jan. 1, 2021 | Oct. 13, 2022 | See Details |
| 482 | SPRYCEL 100 mg film-coated tablets | SPRYCEL 100 mg film-coated tablets Each film-coated tablet contains 100 mg dasatinib (as monohydrate). Excipient with known effect Each film-coated tablet contains 135.0 mg of lactose monohydrate. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). SPRYCEL 100 mg film-coated tablets White to off-white, biconvex, oval film-coated tablet with "BMS 100" debossed on one side and "852" on the other side | Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland | PLGB 15105/0142 | Jan. 1, 2021 | Oct. 13, 2022 | See Details |
| 481 | SPRYCEL 10 mg/mL powder for oral suspension | One bottle of powder for oral suspension contains 990 mg of dasatinib (as monohydrate). After constitution, one bottle contains 99 mL of oral suspension. Each mL of oral suspension contains 10 mg of dasatinib (as monohydrate). Excipient with known effect Each mL of oral suspension contains approximately 291 mg of sucrose, 2.1 mg of sodium, 0.25 mg of sodium benzoate, 0.25 mg of benzoic acid, 0.017 mg of benzyl alcohol and <10 ppm of sulphur dioxide (E220). For the full list of excipients, see section 6.1. | Powder for oral suspension. White to off-white powder. | Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 DO NOT USE A DISHWASHER ALLOW TO AIR DRY AFTER EACH USE DO NOT TAKE APART THE SYRINGE Dublin 15, D15 T867 Ireland | PLGB 15105/1041 | Jan. 1, 2021 | Oct. 13, 2022 | See Details |
| 480 | Omvoh 100 mg solution for injection in pre-filled pen | Omvoh 100 mg solution for injection in pre-filled pen Each pre-filled pen contains 100 mg mirikizumab in 1 mL solution. Mirikizumab is a humanised monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection (injection) The solution is a clear and colourless to slightly yellow solution with a pH of approximately 5.5 and an osmolarity of approximately 300 mOsm/L. | Eli Lilly Nederland B.V. Papendorpseweg 83 3528 BJ Utrecht The Netherlands. | PLGB 14895/0326 | April 16, 2025 | See Details | |
| 479 | Omvoh 100 mg solution for injection in pre-filled syringe | Omvoh 100 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 100 mg mirikizumab in 1 mL solution. Mirikizumab is a humanised monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection (injection) The solution is a clear and colourless to slightly yellow solution with a pH of approximately 5.5 and an osmolarity of approximately 300 mOsm/L. | Eli Lilly Nederland B.V. Papendorpseweg 83 3528 BJ Utrecht The Netherlands. | PLGB 14895/0325 | April 16, 2025 | See Details | |
| 478 | Omvoh 300 mg concentrate for solution for infusion | Each vial contains 300 mg mirikizumab in 15 mL solution (20 mg/mL). After dilution (see section 6.6), the final concentration is approximately 1.1 mg/mL to approximately 4.6 mg/mL for the treatment of ulcerative colitis and approximately 3.6 mg/mL to approximately 9 mg/mL for the treatment of Crohn’s disease. Mirikizumab is a humanised monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Excipients with known effect Each 15 mL vial contains approximately 60 mg sodium. For the full list of excipients, see section 6.1. | Concentrate for solution for infusion (sterile concentrate) The concentrate is a clear and colourless to slightly yellow solution with a pH of approximately 5.5 and an osmolarity of approximately 300 mOsm/L. | Eli Lilly Nederland B.V. Papendorpseweg 83 3528 BJ Utrecht The Netherlands | PLGB 14895/0324 | April 16, 2025 | See Details | |
| 477 | Emgality 120 mg solution for injection in pre-filled pen | Each pre-filled pen contains 120 mg of galcanezumab in 1 mL. Galcanezumab is a recombinant humanised monoclonal antibody produced in Chinese Hamster Ovary cells. For the full list of excipients, see section 6.1. | Solution for injection (injection). The solution is clear and colourless to slightly yellow. | Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands | PLGB 14895/0242 | Sept. 1, 2023 | Sept. 1, 2023 | See Details |
| 476 | LUMYKRAS 240 mg film-coated tablets | LUMYKRAS 240 mg film-coated tablets Each film-coated tablet contains 240 mg of sotorasib. Excipient with known effect Each film-coated tablet contains 52.5 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. | Film-coated tablet. LUMYKRAS 240 mg film-coated tablets Yellow, immediate release, film-coated tablet, oval-shaped (8 mm × 18 mm), debossed with “AMG” on one side and “240” on the opposite side. | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA United Kingdom | PLGB 13832/0101 | Sept. 18, 2025 | Sept. 18, 2025 | See Details |
| 475 | XGEVA 120 mg solution for injection in pre-filled syringe | Each pre-filled syringe contains 120 mg of denosumab in 1.0 mL of solution (120 mg/mL). Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (Chinese hamster ovary cells) by recombinant DNA technology. Excipient with known effects Each 1.0 mL of solution contains 37 mg sorbitol (E420) and 6.1 mg L-phenylalanine. For the full list of excipients, see section 6.1. | Solution for injection (injection). Clear, colourless to slightly yellow solution and may contain trace amounts of translucent to white proteinaceous particles. | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA UK | PLGB 13832/0091 | Feb. 29, 2024 | Jan. 17, 2025 | See Details |
| 474 | Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. | Aranesp 10 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL). Aranesp 20 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL). Aranesp 30 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 30 micrograms of darbepoetin alfa in 0.3 mL (100 mcg/mL). Aranesp 40 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL). Aranesp 50 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 50 micrograms of darbepoetin alfa in 0.5 mL (100 mcg/mL). Aranesp 60 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 mL (200 mcg/mL). Aranesp 80 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL). Aranesp 100 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 mL (200 mcg/mL). Aranesp 130 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 130 micrograms of darbepoetin alfa in 0.65 mL (200 mcg/mL). Aranesp 150 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL). Aranesp 300 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 300 micrograms of darbepoetin alfa in 0.6 mL (500 mcg/mL). Aranesp 500 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL). Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1). For the full list of excipients, see section 6.1. | Solution for injection (injection) in pre-filled syringe. Clear, colourless solution | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA Cambridge United Kingdom | PLGB 13832/0003 | Jan. 1, 2021 | July 28, 2025 | See Details |
| 473 | Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. | Aranesp 10 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL). Aranesp 20 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL). Aranesp 30 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 30 micrograms of darbepoetin alfa in 0.3 mL (100 mcg/mL). Aranesp 40 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL). Aranesp 50 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 50 micrograms of darbepoetin alfa in 0.5 mL (100 mcg/mL). Aranesp 60 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 mL (200 mcg/mL). Aranesp 80 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL). Aranesp 100 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 mL (200 mcg/mL). Aranesp 130 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 130 micrograms of darbepoetin alfa in 0.65 mL (200 mcg/mL). Aranesp 150 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL). Aranesp 300 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 300 micrograms of darbepoetin alfa in 0.6 mL (500 mcg/mL). Aranesp 500 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL). Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1). For the full list of excipients, see section 6.1. | Solution for injection (injection) in pre-filled syringe. Clear, colourless solution | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA Cambridge United Kingdom | PLGB 13832/0003 | Jan. 1, 2021 | July 28, 2025 | See Details |
| 472 | Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. | Aranesp 10 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL). Aranesp 20 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL). Aranesp 30 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 30 micrograms of darbepoetin alfa in 0.3 mL (100 mcg/mL). Aranesp 40 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL). Aranesp 50 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 50 micrograms of darbepoetin alfa in 0.5 mL (100 mcg/mL). Aranesp 60 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 mL (200 mcg/mL). Aranesp 80 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL). Aranesp 100 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 mL (200 mcg/mL). Aranesp 130 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 130 micrograms of darbepoetin alfa in 0.65 mL (200 mcg/mL). Aranesp 150 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL). Aranesp 300 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 300 micrograms of darbepoetin alfa in 0.6 mL (500 mcg/mL). Aranesp 500 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL). Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1). For the full list of excipients, see section 6.1. | Solution for injection (injection) in pre-filled syringe. Clear, colourless solution | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA Cambridge United Kingdom | PLGB 13832/0003 | Jan. 1, 2021 | July 28, 2025 | See Details |
| 471 | XGEVA 120 mg solution for injection | Each vial contains 120 mg of denosumab in 1.7 mL of solution (70 mg/mL). Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (Chinese hamster ovary cells) by recombinant DNA technology. Excipient with known effects Each 1.7 mL of solution contains 78 mg sorbitol (E420). For the full list of excipients, see section 6.1. | Solution for injection (injection). Clear, colourless to slightly yellow solution and may contain trace amounts of translucent to white proteinaceous particles. | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA United Kingdom | PLGB 13832/0046 | Jan. 1, 2021 | March 7, 2025 | See Details |
| 470 | Kyprolis 60 mg powder for solution for infusion | Each vial contains 60 mg of carfilzomib. Excipient with known effect Each vial contains 216 mg sodium. Each vial contains 3,000 mg of cyclodextrin (betadex sulfobutyl ether sodium). After reconstitution, 1 mL of solution contains 2 mg of carfilzomib. For the full list of excipients, see section 6.1. | Powder for solution for infusion. White to off-white lyophilised powder. | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA United Kingdom | PLGB 13832/0023 | Jan. 1, 2021 | Feb. 27, 2024 | See Details |
| 469 | Kyprolis 30 mg powder for solution for infusion | Each vial contains 30 mg of carfilzomib. Excipient with known effect Each vial contains 109 mg sodium. Each vial contains 1,500 mg of cyclodextrin (betadex sulfobutyl ether sodium). After reconstitution, 1 mL of solution contains 2 mg of carfilzomib. For the full list of excipients, see section 6.1. | Powder for solution for infusion. White to off-white lyophilised powder. | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA United Kingdom | PLGB 13832/0023 | Jan. 1, 2021 | Feb. 27, 2024 | See Details |
| 468 | Kyprolis 10 mg powder for solution for infusion | Each vial contains 10 mg of carfilzomib. Excipient with known effect Each vial contains 37 mg sodium. Each vial contains 500 mg of cyclodextrin (betadex sulfobutyl ether sodium). After reconstitution, 1 mL of solution contains 2 mg of carfilzomib. For the full list of excipients, see section 6.1. | Powder for solution for infusion. White to off-white lyophilised powder. | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA United Kingdom | PLGB 13832/0023 | Jan. 1, 2021 | Feb. 27, 2024 | See Details |
| 467 | Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. | Aranesp 10 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL). Aranesp 20 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL). Aranesp 30 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 30 micrograms of darbepoetin alfa in 0.3 mL (100 mcg/mL). Aranesp 40 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL). Aranesp 50 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 50 micrograms of darbepoetin alfa in 0.5 mL (100 mcg/mL). Aranesp 60 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 mL (200 mcg/mL). Aranesp 80 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL). Aranesp 100 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 mL (200 mcg/mL). Aranesp 130 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 130 micrograms of darbepoetin alfa in 0.65 mL (200 mcg/mL). Aranesp 150 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL). Aranesp 300 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 300 micrograms of darbepoetin alfa in 0.6 mL (500 mcg/mL). Aranesp 500 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL). Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1). For the full list of excipients, see section 6.1. | Solution for injection (injection) in pre-filled syringe. Clear, colourless solution | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA Cambridge United Kingdom | PLGB 13832/0003 | Jan. 1, 2021 | July 28, 2025 | See Details |
| 466 | Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. | Aranesp 10 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL). Aranesp 20 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL). Aranesp 30 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 30 micrograms of darbepoetin alfa in 0.3 mL (100 mcg/mL). Aranesp 40 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL). Aranesp 50 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 50 micrograms of darbepoetin alfa in 0.5 mL (100 mcg/mL). Aranesp 60 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 mL (200 mcg/mL). Aranesp 80 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL). Aranesp 100 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 mL (200 mcg/mL). Aranesp 130 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 130 micrograms of darbepoetin alfa in 0.65 mL (200 mcg/mL). Aranesp 150 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL). Aranesp 300 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 300 micrograms of darbepoetin alfa in 0.6 mL (500 mcg/mL). Aranesp 500 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL). Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1). For the full list of excipients, see section 6.1. | Solution for injection (injection) in pre-filled syringe. Clear, colourless solution | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA Cambridge United Kingdom | PLGB 13832/0003 | Jan. 1, 2021 | July 28, 2025 | See Details |
| 465 | Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. | Aranesp 10 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL). Aranesp 20 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL). Aranesp 30 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 30 micrograms of darbepoetin alfa in 0.3 mL (100 mcg/mL). Aranesp 40 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL). Aranesp 50 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 50 micrograms of darbepoetin alfa in 0.5 mL (100 mcg/mL). Aranesp 60 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 mL (200 mcg/mL). Aranesp 80 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL). Aranesp 100 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 mL (200 mcg/mL). Aranesp 130 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 130 micrograms of darbepoetin alfa in 0.65 mL (200 mcg/mL). Aranesp 150 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL). Aranesp 300 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 300 micrograms of darbepoetin alfa in 0.6 mL (500 mcg/mL). Aranesp 500 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL). Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1). For the full list of excipients, see section 6.1. | Solution for injection (injection) in pre-filled syringe. Clear, colourless solution | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA Cambridge United Kingdom | PLGB 13832/0003 | Jan. 1, 2021 | July 28, 2025 | See Details |
| 464 | Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. | Aranesp 10 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL). Aranesp 20 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL). Aranesp 30 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 30 micrograms of darbepoetin alfa in 0.3 mL (100 mcg/mL). Aranesp 40 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL). Aranesp 50 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 50 micrograms of darbepoetin alfa in 0.5 mL (100 mcg/mL). Aranesp 60 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 mL (200 mcg/mL). Aranesp 80 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL). Aranesp 100 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 mL (200 mcg/mL). Aranesp 130 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 130 micrograms of darbepoetin alfa in 0.65 mL (200 mcg/mL). Aranesp 150 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL). Aranesp 300 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 300 micrograms of darbepoetin alfa in 0.6 mL (500 mcg/mL). Aranesp 500 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL). Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1). For the full list of excipients, see section 6.1. | Solution for injection (injection) in pre-filled syringe. Clear, colourless solution | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA Cambridge United Kingdom | PLGB 13832/0003 | Jan. 1, 2021 | July 28, 2025 | See Details |
| 463 | Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. | Aranesp 10 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL). Aranesp 20 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL). Aranesp 30 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 30 micrograms of darbepoetin alfa in 0.3 mL (100 mcg/mL). Aranesp 40 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL). Aranesp 50 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 50 micrograms of darbepoetin alfa in 0.5 mL (100 mcg/mL). Aranesp 60 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 mL (200 mcg/mL). Aranesp 80 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL). Aranesp 100 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 mL (200 mcg/mL). Aranesp 130 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 130 micrograms of darbepoetin alfa in 0.65 mL (200 mcg/mL). Aranesp 150 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL). Aranesp 300 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 300 micrograms of darbepoetin alfa in 0.6 mL (500 mcg/mL). Aranesp 500 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL). Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1). For the full list of excipients, see section 6.1. | Solution for injection (injection) in pre-filled syringe. Clear, colourless solution | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA Cambridge United Kingdom | PLGB 13832/0003 | Jan. 1, 2021 | July 28, 2025 | See Details |
| 462 | Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. | Aranesp 10 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL). Aranesp 20 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL). Aranesp 30 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 30 micrograms of darbepoetin alfa in 0.3 mL (100 mcg/mL). Aranesp 40 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL). Aranesp 50 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 50 micrograms of darbepoetin alfa in 0.5 mL (100 mcg/mL). Aranesp 60 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 mL (200 mcg/mL). Aranesp 80 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL). Aranesp 100 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 mL (200 mcg/mL). Aranesp 130 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 130 micrograms of darbepoetin alfa in 0.65 mL (200 mcg/mL). Aranesp 150 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL). Aranesp 300 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 300 micrograms of darbepoetin alfa in 0.6 mL (500 mcg/mL). Aranesp 500 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL). Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1). For the full list of excipients, see section 6.1. | Solution for injection (injection) in pre-filled syringe. Clear, colourless solution | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA Cambridge United Kingdom | PLGB 13832/0003 | Jan. 1, 2021 | July 28, 2025 | See Details |
| 461 | Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. | Aranesp 10 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL). Aranesp 20 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL). Aranesp 30 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 30 micrograms of darbepoetin alfa in 0.3 mL (100 mcg/mL). Aranesp 40 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL). Aranesp 50 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 50 micrograms of darbepoetin alfa in 0.5 mL (100 mcg/mL). Aranesp 60 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 mL (200 mcg/mL). Aranesp 80 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL). Aranesp 100 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 mL (200 mcg/mL). Aranesp 130 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 130 micrograms of darbepoetin alfa in 0.65 mL (200 mcg/mL). Aranesp 150 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL). Aranesp 300 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 300 micrograms of darbepoetin alfa in 0.6 mL (500 mcg/mL). Aranesp 500 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL). Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1). For the full list of excipients, see section 6.1. | Solution for injection (injection) in pre-filled syringe. Clear, colourless solution | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA Cambridge United Kingdom | PLGB 13832/0003 | Jan. 1, 2021 | July 28, 2025 | See Details |
| 460 | Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. | Aranesp 10 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL). Aranesp 20 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL). Aranesp 30 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 30 micrograms of darbepoetin alfa in 0.3 mL (100 mcg/mL). Aranesp 40 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL). Aranesp 50 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 50 micrograms of darbepoetin alfa in 0.5 mL (100 mcg/mL). Aranesp 60 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 mL (200 mcg/mL). Aranesp 80 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL). Aranesp 100 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 mL (200 mcg/mL). Aranesp 130 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 130 micrograms of darbepoetin alfa in 0.65 mL (200 mcg/mL). Aranesp 150 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL). Aranesp 300 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 300 micrograms of darbepoetin alfa in 0.6 mL (500 mcg/mL). Aranesp 500 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL). Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1). For the full list of excipients, see section 6.1. | Solution for injection (injection) in pre-filled syringe. Clear, colourless solution | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA Cambridge United Kingdom | PLGB 13832/0003 | Jan. 1, 2021 | July 28, 2025 | See Details |
| 459 | Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. | Aranesp 10 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL). Aranesp 20 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL). Aranesp 30 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 30 micrograms of darbepoetin alfa in 0.3 mL (100 mcg/mL). Aranesp 40 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL). Aranesp 50 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 50 micrograms of darbepoetin alfa in 0.5 mL (100 mcg/mL). Aranesp 60 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 mL (200 mcg/mL). Aranesp 80 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL). Aranesp 100 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 mL (200 mcg/mL). Aranesp 130 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 130 micrograms of darbepoetin alfa in 0.65 mL (200 mcg/mL). Aranesp 150 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL). Aranesp 300 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 300 micrograms of darbepoetin alfa in 0.6 mL (500 mcg/mL). Aranesp 500 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL). Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1). For the full list of excipients, see section 6.1. | Solution for injection (injection) in pre-filled syringe. Clear, colourless solution | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA Cambridge United Kingdom | PLGB 13832/0003 | Jan. 1, 2021 | July 28, 2025 | See Details |
| 458 | AMGEVITA 20 mg solution for injection in pre-filled syringe AMGEVITA 40 mg solution for injection in pre-filled syringe AMGEVITA 40 mg solution for injection in pre-filled pen | AMGEVITA 20 mg solution for injection in pre-filled syringe Each single dose pre-filled syringe contains 20 mg of adalimumab in 0.4 mL solution (50 mg/mL). AMGEVITA 40 mg solution for injection in pre-filled syringe Each single dose pre-filled syringe contains 40 mg of adalimumab in 0.8 mL solution (50 mg/mL). AMGEVITA 40 mg solution for injection in pre-filled pen Each single dose pre-filled pen contains 40 mg of adalimumab in 0.8 mL solution (50 mg/mL). Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells. For the full list of excipients, see section 6.1. | Solution for injection (injection) Solution for injection (injection) in pre-filled pen (SureClick) Clear and colourless to slightly yellow solution. | Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA United Kingdom 54 | PLGB 13832/0001 | April 14, 2022 | July 26, 2024 | See Details |
| 457 | elmiron 100 mg hard capsules | Each hard capsule contains 100 mg of pentosan polysulfate sodium. For the full list of excipients, see section 6.1. | Hard capsule. White opaque capsules size 2. | bene-Arzneimittel GmbH Herterichstrasse 1-3 D-81479 Munich tel: ++49 (0) 89 / 7 49 87-0 fax: ++49 (0) 89 / 7 49 87-142 e-mail: contact@bene-arzneimittel.de | PLGB 12404/0001 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 456 | Emtricitabine/Tenofovir Alafenamide Gilead® 200 mg/25 mg film-coated tablets | Each tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide. | Film-coated tablet. Blue, rectangular-shaped, film-coated tablet of dimensions 12.5 mm x 6.4 mm debossed with “GSI” on one side and “225” on the other side of the tablet. | Gilead Sciences Ltd 280 High Holborn London WC1V 7EE United Kingdom | PLGB 11972/0011 | Jan. 1, 2021 | Oct. 2, 2025 | See Details |
| 455 | Emtricitabine/Tenofovir Alafenamide Gilead® 200 mg/10 mg film-coated tablets | Each tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide. | Film-coated tablet. Grey, rectangular-shaped, film-coated tablet of dimensions 12.5 mm x 6.4 mm debossed with “GSI” on one side and “210” on the other side of the tablet. | Gilead Sciences Ltd 280 High Holborn London WC1V 7EE United Kingdom | PLGB 11972/0010 | Jan. 1, 2021 | Oct. 2, 2025 | See Details |
| 454 | Quofenix 450 mg tablets | Each tablet contains delafloxacin meglumine equivalent to 450 mg delafloxacin. Excipient(s) with known effect: Each tablet contains 39 mg of sodium. For the full list of excipients, see section 6.1. | Tablet. Beige to mottled beige, oblong biconvex tablets of approximately 10 mm width x 21 mm length. | A. Menarini – Industrie Farmaceutiche Riunite – s.r.l. Via Sette Santi 3, 50131 Florence, Italy | PLGB 10649/0010 | Jan. 1, 2021 | Jan. 9, 2025 | See Details |
| 453 | Febuxostat Mylan 120 mg film-coated tablets | Each tablet contains 120 mg of febuxostat. Excipient with known effect Each tablet contains 354.0 mg of lactose For the full list of excipients, see section 6.1. | Film-coated tablet. A yellow, capsule shaped, biconvex tablet, approximately 18 x 8 mm, debossed with M on one side of the tablet and FX4 on the other side. | Generics (UK) Limited t/a Mylan Station Close, Potters Bar, EN6 1TL, United Kingdom | PLGB 04569/2003 | Jan. 1, 2021 | July 17, 2023 | See Details |
| 452 | Rivastigmine Sandoz 2 mg/ml oral solution | Each ml contains rivastigmine hydrogen tartrate corresponding to 2 mg rivastigmine. Excipient with known effect Each ml contains 1 mg of sodium benzoate. For the full list of excipients, see section 6.1. | Oral solution Clear, yellow solution. | Sandoz GmbH Biochemiestraße 10 A-6250 Kundl Austria | PLGB 04520/0221 | Jan. 1, 2021 | July 23, 2024 | See Details |
| 451 | Xenpozyme 20 mg powder for concentrate for solution for infusion | Each vial contains 20 mg of olipudase alfa*. After reconstitution, each vial contains 4 mg of olipudase alfa per mL. Each vial must be further diluted before use (see section 6.6). *Olipudase alfa is a recombinant human acid sphingomyelinase and is produced in a Chinese Hamster Ovary (CHO) cell line by recombinant DNA technology. Excipient with known effect Each vial contains 3.02 mg of sodium. For the full list of excipients, see section 6.1. | Powder for concentrate for solution for infusion (powder for concentrate). White to off-white lyophilised powder. | Aventis Pharma Ltd 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK Trading as: Sanofi 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK | PLGB 04425/0901 | Aug. 18, 2025 | See Details | |
| 450 | Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen | Each pre-filled pen contains 300 units of insulin glargine* and 150 micrograms of lixisenatide in 3 ml solution. Each ml contains 100 units of insulin glargine and 50 micrograms of lixisenatide. Each dose step contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide *Insulin glargine is produced by recombinant DNA technology in Escherichia coli. The dose window on the pen shows the number of dose steps. Excipient(s) with known effects: Each ml contains 2.7 milligrams of metacresol. For the full list of excipients, see section 6.1. | Solution for injection in pre-filled pen (SoloStar) Clear colourless solution. | See Details | ||||
| 449 | Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen | Each pre-filled pen contains 300 units of insulin glargine and 100 micrograms of lixisenatide in 3 ml solution. Each ml contains 100 units of insulin glargine and 33 micrograms of lixisenatide. Each dose step contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide. *Insulin glargine is produced by recombinant DNA technology in Escherichia coli. The dose window on the pen shows the number of dose steps. Excipient(s) with known effects: Each ml contains 2.7 milligrams of metacresol. For the full list of excipients, see section 6.1. | Solution for injection in pre-filled pen (SoloStar) Clear colourless solution. | See Details | ||||
| 448 | Wyost 120 mg solution for injection | Each vial contains 120 mg of denosumab in 1.7 mL of solution (70 mg/mL). Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (Chinese hamster ovary cells) by recombinant DNA technology. Excipient with known effect Each 1.7 mL of solution contains 78.9 mg sorbitol (E 420). For the full list of excipients, see section 6.1. | Solution for injection (injection). Clear to slightly opalescent, colourless to slightly yellowish or slightly brownish solution with a pH between 4.9 and 5.5 and an osmolality of 245 – 345 mOsmol/kg. | Sandoz Limited Park view, Riverside way Watchmoor park Camberley, Surrey GU15 3YL United Kingdom | PLGB 04416/1710 | Nov. 7, 2024 | Nov. 12, 2025 | See Details |
| 447 | Rivastigmine 6 mg orodispersible tablets | Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 6 mg rivastigmine. Excipient with known effect: Each orodispersible tablet contains 21 µg sorbitol (E420). For the full list of excipients, see section 6.1. | Orodispersible tablet The tablets are round and white. | KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia | PLGB 01656/0324 | Jan. 1, 2021 | Feb. 24, 2025 | See Details |
| 446 | Rivastigmine 6 mg hard capsules | Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 6 mg rivastigmine. For the full list of excipients, see section 6.1. | Hard capsule White to almost white powder in a capsule with a brownish red cap and orange body. | KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia | PLGB 01656/0323 | Jan. 1, 2021 | Feb. 24, 2025 | See Details |
| 445 | Rivastigmine 4.5 mg orodispersible tablets | Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 4.5 mg rivastigmine. Excipient with known effect: Each orodispersible tablet contains 15.75 µg sorbitol (E420). For the full list of excipients, see section 6.1. | Orodispersible tablet The tablets are round and white. | KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia | PLGB 01656/0322 | Jan. 1, 2021 | Feb. 24, 2025 | See Details |
| 444 | Rivastigmine 4.5 mg hard capsules | Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 4.5 mg rivastigmine. For the full list of excipients, see section 6.1. | Hard capsule White to almost white powder in a capsule with brownish red cap and brownish red body. | KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia | PLGB 01656/0321 | Jan. 1, 2021 | Feb. 24, 2025 | See Details |
| 443 | Rivastigmine 3 mg orodispersible tablets | Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 3 mg rivastigmine. Excipient with known effect: Each orodispersible tablet contains 10.5 µg sorbitol (E420). For the full list of excipients, see section 6.1. | Orodispersible tablet The tablets are round and white. | KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia | PLGB 01656/0320 | Jan. 1, 2021 | Feb. 24, 2025 | See Details |
| 442 | Rivastigmine 3 mg hard capsules | Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 3 mg rivastigmine. For the full list of excipients, see section 6.1. | Hard capsule White to almost white powder in a capsule with orange cap and orange body. | KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia | PLGB 01656/0319 | Jan. 1, 2021 | Feb. 24, 2025 | See Details |
| 441 | Rivastigmine 1.5 mg orodispersible tablets | Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 1.5 mg rivastigmine. Excipient with known effect: Each orodispersible tablet contains 5.25 µg sorbitol (E420). For the full list of excipients, see section 6.1. | Orodispersible tablet The tablets are round and white. | KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia | PLGB 01656/0318 | Jan. 1, 2021 | Feb. 24, 2025 | See Details |
| 440 | Rivastigmine 1.5 mg hard capsules | Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg rivastigmine. For the full list of excipients, see section 6.1. | Hard capsule White to almost white powder in a capsule with yellow cap and yellow body. | KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia | PLGB 01656/0317 | Jan. 1, 2021 | Feb. 24, 2025 | See Details |
| 439 | Febuxostat Krka 120 mg film-coated tablets | Each film-coated tablet contains 120 mg febuxostat. Excipient(s) with known effect - lactose (as monohydrate): 109 mg For the full list of excipients, see section 6.1. | Film-coated tablet (tablet) Brownish yellow, slightly biconvex, capsule shaped film-coated tablets scored on both sides. Tablet dimension: approximatelly 19 mm × 8 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. | KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia | PLGB 01656/0308 | Oct. 12, 2023 | March 8, 2024 | See Details |
| 438 | Gilteritinib Astellas 40 mg film-coated tablets | Each film-coated tablet contains 40 mg gilteritinib (as fumarate). For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Round, light yellow film-coated tablet of approximately 7.1 mm, debossed with the company logo and ‘235’ on the same side. | Astellas Pharma Ltd. 300 Dashwood Lang Road Bourne Business Park Addlestone United Kingdom KT15 2NX | PLGB 00166/0425 | June 27, 2024 | See Details | |
| 437 | Ilaris 150 mg solution for injection in pre-filled pen | Ilaris 150 mg solution for injection in pre-filled pen Each pre-filled pen contains 150 mg canakinumab in 1 ml. Canakinumab is a human monoclonal antibody produced in mouse myeloma Sp2/0 cells by recombinant DNA technology. Excipient with known effect The solution for injection contains 0.4 mg/ml polysorbate 80. For the full list of excipients, see section 6.1. | Solution for injection (injection) in pre-filled pen (SensoReady Pen). The solution is clear to opalescent and colourless to slightly brownish yellow with a pH of approximately 6.5 and osmolality of 350 to 450 mOsm/kg. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1238 | Feb. 4, 2025 | Feb. 4, 2025 | See Details |
| 436 | Jakavi 5mg/ml oral solution | 1 ml oral solution contains 5 mg ruxolitinib (as phosphate) Each 60 ml bottle contains 300 mg of ruxolitinib (as phosphate). Excipients with known effect This medicine contains 150 mg of propylene glycol, 1.2 mg methyl parahydroxybenzoate and 0.4 mg propyl parahydroxybenzoate in each ml of oral solution (see section 4.4). For the full list of excipients, see section 6.1. | Oral solution. Clear, colourless to light yellow solution, minor colourless particles or slight sediment intrinsic to the solution may be observed. | Novartis Pharmaceuticals UK Limited 2nd Floor, WestWorks Building, White City Place 195 Wood Lane W12 7FQ UK | PLGB 00101/1236 | Aug. 7, 2025 | Aug. 7, 2025 | See Details |
| 435 | Simulect® 20 mg powder for solution for injection or infusion | Each vial contains 20 mg basiliximab*. One ml of the reconstituted solution contains 4 mg basiliximab. * recombinant murine/human chimeric monoclonal antibody directed against the interleukin-2 receptor a-chain (CD25 antigen) produced in a mouse myeloma cell line by recombinant DNA technology. For the full list of excipients, see section 6.1. | Powder for solution for injection or infusion White powder | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1235 | Jan. 12, 2024 | Jan. 12, 2024 | See Details |
| 434 | Simulect® 10 mg powder for solution for injection or infusion | Each vial contains 10 mg basiliximab*. One ml of the reconstituted solution contains 4 mg basiliximab. * recombinant murine/human chimeric monoclonal antibody directed against the interleukin-2 receptor a-chain (CD25 antigen) produced in a mouse myeloma cell line by recombinant DNA technology. For the full list of excipients, see section 6.1. | Powder for solution for injection or infusion White powder | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1234 | Jan. 12, 2024 | Jan. 12, 2024 | See Details |
| 433 | Locametz 25 micrograms kit for radiopharmaceutical preparation | The vial contains 25 micrograms of gozetotide. The radionuclide is not part of the kit. Excipient with known effect The vial contains 28.97 mg of sodium. For the full list of excipients, see section 6.1. | Kit for radiopharmaceutical preparation containing one vial of white lyophilised powder (powder for solution for injection). For radiolabelling with gallium-68 chloride solution. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1232 | Aug. 10, 2022 | See Details | |
| 432 | FABHALTA 200 mg hard capsules | Each capsule contains iptacopan hydrochloride monohydrate equivalent to 200 mg iptacopan. For the full list of excipients, see section 6.1. | Hard capsule (capsule) Size 0 pale yellow, opaque hard capsule (21.2 to 22.2 mm) with “LNP200” on the body and “NVR” on the cap, containing white or almost white to pale purplish-pink powder. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1231 | Aug. 2, 2024 | Nov. 28, 2025 | See Details |
| 431 | Lutathera® 370 MBq/mL solution for infusion | One mL of solution contains 370 MBq of lutetium (177Lu) oxodotreotide at the date and time of calibration. The total amount of radioactivity per single-dose vial is 7 400 MBq at the date and time of infusion. Given the fixed volumetric activity of 370 MBq/mL at the date and time of calibration, the volume of the solution in the vial ranges between 20.5 and 25.0 mL in order to provide the required amount of radioactivity at the date and time of infusion. Physical characteristics Lutetium-177 has a half-life of 6.647 days. Lutetium-177 decays by ß- emission to stable hafnium-177 with the most abundant ß- (79.3%) having a maximum energy of 0.498 MeV. The average beta energy is approximately 0.13 MeV. Low gamma energy is also emitted, for instance at 113 keV (6.2%) and 208 keV (11%). Excipient with known effect Each mL of solution contains up to 0.14 mmol (3.2 mg) of sodium. For the full list of excipients, see section 6.1. | Solution for infusion. Clear, colourless to slightly yellow solution. | Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1230 | May 17, 2023 | See Details | |
| 430 | SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation | Each vial of powder contains 40 micrograms of edotreotide. The radionuclide is not part of the kit. For the full list of excipients, see section 6.1. | Kit for radiopharmaceutical preparation containing: - Powder for solution for injection: the vial contains a white lyophilised powder. - Reaction buffer: the vial contains a clear, colourless solution. For radiolabelling with gallium (68Ga) chloride solution. | Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1229 | Jan. 1, 2021 | See Details | |
| 429 | Spexotras® 0.05 mg/ml powder for oral solution | One bottle contains trametinib dimethyl sulfoxide equivalent to 4.7 mg of trametinib. Each ml of the reconstituted solution contains 0.05 mg of trametinib. Excipients with known effect Each ml of the reconstituted solution contains 100 mg of sulfobutylbetadex sodium, 0.8 mg of methyl parahydroxybenzoate and 1.98 mg of sodium. For the full list of excipients, see section 6.1. | Powder for oral solution. White or almost white powder. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane L o n d o n W 1 2 7 F Q United Kingdom | PLGB 00101/1227 | Feb. 13, 2024 | Sept. 3, 2025 | See Details |
| 428 | Entresto® 15 mg/16 mg granules in capsules for opening | Each capsule contains ten granules equivalent to 15.18 mg sacubitril and 16.07 mg valsartan (as sacubitril valsartan sodium salt complex). For the full list of excipients, see section 6.1. | Granules in capsules for opening (granules in capsule) The granules are white to slightly yellow in colour and round, biconvex in shape and approximately 2 mm in diameter. They are provided in a hard capsule which must be opened prior to administration. The capsule consists of a yellow coloured cap, marked “10” in red and a transparent body, marked “NVR” in red. An arrow is printed on both the body and the cap. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1226 | Aug. 25, 2023 | Sept. 15, 2025 | See Details |
| 427 | Entresto® 6 mg/6 mg granules in capsules for opening | Each capsule contains four granules equivalent to 6.1 mg sacubitril and 6.4 mg valsartan (as sacubitril valsartan sodium salt complex). For the full list of excipients, see section 6.1. | Granules in capsules for opening (granules in capsule) The granules are white to slightly yellow in colour and round, biconvex in shape and approximately 2 mm in diameter. They are provided in a hard capsule which must be opened prior to administration. The capsule consists of a white coloured cap, marked “04” in red and a transparent body, marked “NVR” in red. An arrow is printed on both the body and the cap. | See Details | ||||
| 426 | LysaKare 25 g/25 g solution for infusion | One 1,000 mL bag contains 25 g of L-arginine hydrochloride and 25 g of L-lysine hydrochloride. For the full list of excipients, see section 6.1. | Solution for infusion Clear, colourless solution, free from visible particles pH: 5.1 to 6.1 Osmolality: 420 to 480 mOsm/kg | Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1224 | Jan. 1, 2021 | Sept. 19, 2025 | See Details |
| 425 | Zolgensma 2 × 1013 vector genomes/mL solution for infusion | 2.1 General description Onasemnogene abeparvovec is a gene therapy medicinal product that expresses the human survival motor neuron (SMN) protein. It is a non-replicating recombinant adeno-associated virus serotype 9 (AAV9) based vector containing the cDNA of the human SMN gene under the control of the cytomegalovirus enhancer/chicken-ß- actin-hybrid promoter. Onasemnogene abeparvovec is produced in human embryonic kidney cells by recombinant DNA technology. 2. Each mL contains onasemnogene abeparvovec with a nominal concentration of 2 × 1013 vector genomes (vg). Vials will contain an extractable volume of not less than either 5.5 mL or 8.3 mL. The total number of vials and combination of fill volumes in each finished pack will be customised to meet dosing requirements for individual patients depending on their weight (see sections 4.2 and 6.5). Excipient with known effect This medicinal product contains 0.2 mmol sodium per mL For the full list of excipients, see section 6.1. | Solution for infusion. A clear to slightly opaque, colourless to faint white solution. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ | PLGB 00101/1223 | Jan. 2, 2024 | See Details | |
| 424 | Xolair® 75 mg solution for injection in pre-filled pen | Each pre-filled pen contains 75 mg of omalizumab* in 0.5 ml solution. *Omalizumab is a humanised monoclonal antibody produced in a Chinese hamster ovary (CHO) mammalian cell line by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection (injection) Clear to slightly opalescent, colourless to pale brownish-yellow solution. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1222 | Feb. 28, 2024 | Feb. 28, 2024 | See Details |
| 423 | Xolair® 150 mg solution for injection in pre-filled pen | Each pre-filled pen contains 150 mg of omalizumab* in 1 ml solution. *Omalizumab is a humanised monoclonal antibody produced in a Chinese hamster ovary (CHO) mammalian cell line by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection (injection) Clear to slightly opalescent, colourless to pale brownish-yellow solution. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1221 | Feb. 28, 2024 | Nov. 28, 2025 | See Details |
| 422 | Xolair® 300 mg solution for injection in pre-filled pen | Each pre-filled pen contains 300 mg of omalizumab* in 2 ml solution. *Omalizumab is a humanised monoclonal antibody produced in a Chinese hamster ovary (CHO) mammalian cell line by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection (injection) Clear to slightly opalescent, colourless to pale brownish-yellow solution. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1220 | Feb. 28, 2024 | Feb. 28, 2024 | See Details |
| 421 | Xolair® 300 mg solution for injection in pre-filled syringe | Each pre-filled syringe contains 300 mg of omalizumab* in 2 ml solution. *Omalizumab is a humanised monoclonal antibody produced in a Chinese hamster ovary (CHO) mammalian cell line by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection (injection) Clear to slightly opalescent, colourless to pale brownish-yellow solution. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1219 | Feb. 28, 2024 | Feb. 28, 2024 | See Details |
| 420 | Tabrecta 200 mg film-coated tablets | Tabrecta 200 mg film-coated tablets Each film-coated tablet contains capmatinib dihydrochloride monohydrate equivalent to 200 mg capmatinib. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet) Tabrecta 200 mg film-coated tablets Yellow, ovaloid, curved film-coated tablet with bevelled edges, unscored, debossed with “LO” on one side and “NVR” on the other side. Approximate size: 20 mm (length) x 8 mm (width). | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ | PLGB 00101/1218 | March 27, 2023 | Dec. 19, 2023 | See Details |
| 419 | Tabrecta 150 mg film-coated tablets | Tabrecta 150 mg film-coated tablets Each film-coated tablet contains capmatinib dihydrochloride monohydrate equivalent to 150 mg capmatinib. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet) Tabrecta 150 mg film-coated tablets Pale orange brown, ovaloid, curved film-coated tablet with bevelled edges, unscored, debossed with “DU” on one side and “NVR” on the other side. Approximate size: 18 mm (length) x 7 mm (width). | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ | PLGB 00101/1217 | March 27, 2023 | Dec. 19, 2023 | See Details |
| 418 | Beovu 120 mg/ml solution for injection | One ml solution for injection contains 120 mg of brolucizumab*. * Brolucizumab is a humanised monoclonal single-chain Fv (scFv) antibody fragment produced in Escherichia coli cells by recombinant DNA technology. Beovu 120 mg/ml solution for injection Each vial contains 27.6 mg brolucizumab in 0.23 ml solution. This provides a usable amount to deliver a single dose of 0.05 ml solution containing 6 mg of brolucizumab. Excipient with known effect Each vial contains 0.05 mg polysorbate 80 in 0.23 ml solution. This corresponds to 0.01 mg polysorbate 80 per dose (0.05 ml). For the full list of excipients, see section 6.1. | Solution for injection (injection). Clear to slightly opalescent, colourless to slightly brownish-yellow aqueous solution. | Novartis Pharmaceuticals UK Limited 2nd Floor, The West Works Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1211 | July 21, 2025 | See Details | |
| 417 | Enerzair® Breezhaler® 114 micrograms/46 micrograms/136 micrograms inhalation powder, hard capsules | Each capsule contains 150 mcg indacaterol (as acetate), 63 mcg glycopyrronium bromide equivalent to 50 mcg glycopyrronium and 160 mcg mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 114 mcg indacaterol (as acetate), 58 mcg glycopyrronium bromide equivalent to 46 mcg glycopyrronium and 136 mcg mometasone furoate. Excipient with known effect Each capsule contains 25 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. | Inhalation powder, hard capsule (inhalation powder). Capsule with green transparent cap and uncoloured transparent body containing a white powder, with the product code “IGM150-50-160” printed in black above two black bars on the body and with the product logo printed in black and surrounded by a black bar on the cap. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom Base Cap Side buttons Blister Screen Capsule chamber Inhaler Inhaler base Blister card Mouthpiece | PLGB 00101/1209 | June 5, 2025 | June 5, 2025 | See Details |
| 416 | Scemblix 40® mg film-coated tablets | Scemblix 40 mg film-coated tablets Each film-coated tablet contains asciminib hydrochloride, equivalent to 40 mg asciminib. Excipients with known effect Each film-coated tablet contains 86 mg lactose monohydrate. For the full list of excipients, see section 6.1. | Film-coated tablet. Scemblix 40 mg film-coated tablets Violet white, round, biconvex film-coated tablets with bevelled edges of approximately 8 mm diameter, unscored, debossed with company logo on one side and “40” on the other side. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1208 | June 15, 2022 | Aug. 18, 2025 | See Details |
| 415 | Scemblix 20® mg film-coated tablets | Scemblix 20 mg film-coated tablets Each film-coated tablet contains asciminib hydrochloride, equivalent to 20 mg asciminib. Excipients with known effect Each film-coated tablet contains 43 mg lactose monohydrate. For the full list of excipients, see section 6.1. | Film-coated tablet. 20 mg film-coated tablets Pale yellow, round, biconvex film-coated tablets with bevelled edges of approximately 6 mm diameter, unscored, debossed with company logo on one side and “20” on the other side. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1207 | June 15, 2022 | Aug. 18, 2025 | See Details |
| 414 | Zykadia® 150 mg hard capsules | Each hard capsule contains 150 mg ceritinib. For the full list of excipients, see section 6.1. | Hard capsule. Capsule with white opaque body and blue opaque cap, with “LDK 150MG” imprinted on the cap and “NVR” on the body, containing white to almost white powder. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1206 | Jan. 1, 2021 | Sept. 12, 2024 | See Details |
| 413 | Cosentyx 75 mg solution for injection in pre-filled syringe | Each pre-filled syringe contains 75 mg secukinumab in 0.5 ml. Secukinumab is a recombinant fully human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells. For the full list of excipients, see section 6.1. | Solution for injection (injection) The solution is clear and colourless to slightly yellow. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1205 | July 26, 2021 | Aug. 5, 2025 | See Details |
| 412 | Leqvio® 284 mg solution for injection in pre-filled syringe | Each pre-filled syringe contains inclisiran sodium equivalent to 284 mg inclisiran in 1.5 ml solution. Each ml contains inclisiran sodium equivalent to 189 mg inclisiran. For the full list of excipients, see section 6.1. | Solution for injection (injection). The solution is clear, colourless to pale yellow, and essentially free of particulates. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1202 | Nov. 11, 2025 | Nov. 11, 2025 | See Details |
| 411 | Kesimpta 20 mg solution for injection in pre-filled pen | Each pre-filled pen contains 20 mg ofatumumab in 0.4 ml solution (50 mg/ml). Ofatumumab is a fully human monoclonal antibody produced in a murine cell line (NS0) by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection (injection) in pre-filled pen (Sensoready Pen) The solution is clear to slightly opalescent, and colourless to slightly brownish- yellow. | Novartis Pharmaceuticals UK Limited. 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1201 | April 6, 2021 | Dec. 30, 2024 | See Details |
| 410 | Kesimpta 20 mg solution for injection in pre-filled syringe | Each pre-filled syringe contains 20 mg ofatumumab in 0.4 ml solution (50 mg/ml). Ofatumumab is a fully human monoclonal antibody produced in a murine cell line (NS0) by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection (injection) The solution is clear to slightly opalescent, and colourless to slightly brownish- yellow. | Novartis Pharmaceuticals UK Limited. 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1200 | April 6, 2021 | Dec. 30, 2024 | See Details |
| 409 | Cosentyx 300 mg solution for injection in pre-filled syringe | Cosentyx 300 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 300 mg secukinumab in 2 ml. Secukinumab is a recombinant fully human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells. For the full list of excipients, see section 6.1. | Solution for injection (injection) The solution is clear and colourless to slightly yellow. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1199 | Jan. 1, 2021 | Aug. 5, 2025 | See Details |
| 408 | Cosentyx 300 mg solution for injection in pre-filled pen | Cosentyx 300 mg solution for injection in pre-filled pen Each pre-filled pen contains 300 mg secukinumab in 2 ml. Secukinumab is a recombinant fully human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells. For the full list of excipients, see section 6.1. | Solution for injection (injection) The solution is clear and colourless to slightly yellow. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1198 | Jan. 1, 2021 | Aug. 5, 2025 | See Details |
| 407 | Beovu 120 mg/ml solution for injection in pre-filled syringe | One ml solution for injection contains 120 mg of brolucizumab*. * Brolucizumab is a humanised monoclonal single-chain Fv (scFv) antibody fragment produced in Escherichia coli cells by recombinant DNA technology. Beovu 120 mg/ml solution for injection in pre-filled syringe Each pre-filled syringe contains 19.8 mg brolucizumab in 0.165 ml solution. This provides a usable amount to deliver a single dose of 0.05 ml solution containing 6 mg of brolucizumab. Excipient with known effect Each pre-filled syringe contains 0.03 mg polysorbate 80 in 0.165 ml solution. This corresponds to 0.01 mg polysorbate 80 per dose (0.05 ml). For the full list of excipients, see section 6.1. | Solution for injection (injection). Clear to slightly opalescent, colourless to slightly brownish-yellow aqueous solution. | Novartis Pharmaceuticals UK Limited 2nd Floor, The West Works Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1197 | Nov. 22, 2024 | July 21, 2025 | See Details |
| 406 | Zykadia® 150 mg film-coated tablets | Each film-coated tablet contains 150 mg ceritinib. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet) Light blue, round, biconvex film-coated tablet with bevelled edges, without score, debossed with “NVR” on one side and “ZY1” on the other side. Approximate diameter: 9.1 mm. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1196 | Jan. 1, 2021 | July 13, 2021 | See Details |
| 405 | Mayzent® 2 mg film-coated tablets | Mayzent 0.25 mg film-coated tablets Each film-coated tablet contains siponimod fumaric acid equivalent to 0.25 mg siponimod. Excipients with known effect Each tablet contains 59.1 mg lactose (as monohydrate) and 0.092 mg soya lecithin. Mayzent 1 mg film-coated tablets Each film-coated tablet contains siponimod fumaric acid equivalent to 1 mg siponimod. Excipients with known effect Each tablet contains 58.3 mg lactose (as monohydrate) and 0.092 mg soya lecithin. Mayzent 2 mg film-coated tablets Each film-coated tablet contains siponimod fumaric acid equivalent to 2 mg siponimod. Excipients with known effect Each tablet contains 57.3 mg lactose (as monohydrate) and 0.092 mg soya lecithin. For the full list of excipients, see section 6.1. | Film-coated tablet Mayzent 2 mg film-coated tablets Pale yellow, round, biconvex, bevelled-edged film-coated tablet of approximately 6.1 mm diameter with company logo on one side and “II” on the other side. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1190 | April 28, 2025 | April 29, 2025 | See Details |
| 404 | Atectura® Breezhaler® 125 micrograms/260 micrograms inhalation powder, hard capsules | Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg indacaterol (as acetate) and 80 mcg mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg indacaterol (as acetate) and 62.5 mcg mometasone furoate. Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg indacaterol (as acetate) and 160 mcg mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg indacaterol (as acetate) and 127.5 mcg mometasone furoate. Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg of indacaterol (as acetate) and 320 mcg mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg indacaterol (as acetate) and 260 mcg mometasone furoate. Excipient with known effect Each capsule contains approximately 24 mg lactose monohydrate. For the full list of excipients, see section 6.1. | Inhalation powder, hard capsule (inhalation powder). Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Transparent capsules containing a white powder, with the product code “IM150 80” printed in blue above one blue bar on the body and with the product logo printed in blue and surrounded by two blue bars on the cap. Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Transparent capsules containing a white powder, with the product code “IM150 160” printed in grey on the body and with the product logo printed in grey on the cap. Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules Transparent capsules containing a white powder, with the product code “IM150 320” printed in black above two black bars on the body and with the product logo printed in black and surrounded by two black bars on the cap. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1188 | June 4, 2025 | June 4, 2025 | See Details |
| 403 | Atectura® Breezhaler® 125 micrograms/127.5 micrograms inhalation powder, hard capsules | Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg indacaterol (as acetate) and 80 mcg mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg indacaterol (as acetate) and 62.5 mcg mometasone furoate. Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg indacaterol (as acetate) and 160 mcg mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg indacaterol (as acetate) and 127.5 mcg mometasone furoate. Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg of indacaterol (as acetate) and 320 mcg mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg indacaterol (as acetate) and 260 mcg mometasone furoate. Excipient with known effect Each capsule contains approximately 24 mg lactose monohydrate. For the full list of excipients, see section 6.1. | Inhalation powder, hard capsule (inhalation powder). Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Transparent capsules containing a white powder, with the product code “IM150 80” printed in blue above one blue bar on the body and with the product logo printed in blue and surrounded by two blue bars on the cap. Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Transparent capsules containing a white powder, with the product code “IM150 160” printed in grey on the body and with the product logo printed in grey on the cap. Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules Transparent capsules containing a white powder, with the product code “IM150 320” printed in black above two black bars on the body and with the product logo printed in black and surrounded by two black bars on the cap. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1187 | June 4, 2025 | June 4, 2025 | See Details |
| 402 | Atectura® Breezhaler® 125 micrograms/62.5 micrograms inhalation powder, hard capsules | Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg indacaterol (as acetate) and 80 mcg mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg indacaterol (as acetate) and 62.5 mcg mometasone furoate. Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg indacaterol (as acetate) and 160 mcg mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg indacaterol (as acetate) and 127.5 mcg mometasone furoate. Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg of indacaterol (as acetate) and 320 mcg mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg indacaterol (as acetate) and 260 mcg mometasone furoate. Excipient with known effect Each capsule contains approximately 24 mg lactose monohydrate. For the full list of excipients, see section 6.1. | Inhalation powder, hard capsule (inhalation powder). Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Transparent capsules containing a white powder, with the product code “IM150 80” printed in blue above one blue bar on the body and with the product logo printed in blue and surrounded by two blue bars on the cap. Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Transparent capsules containing a white powder, with the product code “IM150 160” printed in grey on the body and with the product logo printed in grey on the cap. Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules Transparent capsules containing a white powder, with the product code “IM150 320” printed in black above two black bars on the body and with the product logo printed in black and surrounded by two black bars on the cap. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1186 | June 4, 2025 | June 4, 2025 | See Details |
| 401 | Piqray®150 mg film coated tablets | Piqray 150 mg film coated tablets Each film coated tablet contains 150 mg of alpelisib. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Light red, ovaloid, curved film-coated tablet with bevelled edges, imprinted with “YL7” on one side and “NVR” on the other side. Approximate size: 16.2 mm (length); 6.5 mm (width). | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom 32 | PLGB 00101/1182 | Oct. 23, 2025 | Jan. 26, 2026 | See Details |
| 400 | Piqray®150 mg film coated tablets | Piqray 150 mg film coated tablets Each film coated tablet contains 150 mg of alpelisib. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Piqray 50 mg film-coated tablets Light pink, round, curved film-coated tablet with bevelled edges, imprinted with “L7” on one side and “NVR” on the other side. Approximate diameter: 7.2 mm. Piqray 200 mg film-coated tablets Light red, ovaloid, curved film-coated tablet with bevelled edges, imprinted with “YL7” on one side and “NVR” on the other side. Approximate size: 16.2 mm (length); 6.5 mm (width). | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom 32 | PLGB 00101/1181 | Oct. 23, 2025 | Jan. 26, 2026 | See Details |
| 399 | Piqray®150 mg film coated tablets | Piqray 150 mg film coated tablets Each film coated tablet contains 150 mg of alpelisib. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Pale red, ovaloid, curved film-coated tablet with bevelled edges, imprinted with “UL7” on one side and “NVR” on the other side. Approximate size: 14.2 mm (length); 5.7 mm (width). | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ 32 United Kingdom | PLGB 00101/1180 | Oct. 23, 2025 | Jan. 26, 2026 | See Details |
| 398 | Xolair® 75 mg solution for injection in pre-filled syringe | One vial contains 75 mg of omalizumab*. After reconstitution one vial contains 125 mg/ml of omalizumab (75 mg in 0.6 ml). *Omalizumab is a humanised monoclonal antibody produced in a Chinese hamster ovary (CHO) mammalian cell line by recombinant DNA technology. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection Powder: white to off-white lyophilisate Solvent: clear and colourless solution | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1172 | Jan. 1, 2021 | Feb. 28, 2024 | See Details |
| 397 | Xolair 150 mg powder and solvent for solution for injection | One vial contains 150 mg of omalizumab*. After reconstitution one vial contains 125 mg/ml of omalizumab (150 mg in 1.2 ml). *Omalizumab is a humanised monoclonal antibody produced in a Chinese hamster ovary (CHO) mammalian cell line by recombinant DNA technology. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection Powder: white to off-white lyophilisate Solvent: clear and colourless solution | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1170 | Jan. 1, 2021 | Feb. 28, 2024 | See Details |
| 396 | Votubia® 1 mg dispersible tablets | Each dispersible tablet contains 1 mg everolimus. Excipient with known effect Each dispersible tablet contains 0.98 mg lactose. For the full list of excipients, see section 6.1. | Dispersible tablet. White to slightly yellowish, round, flat tablets of approximately 7.1 mm in diameter, with a bevelled edge and no score, engraved with “D1” on one side and “NVR” on the other. | Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1162 | Jan. 1, 2021 | July 12, 2022 | See Details |
| 395 | Votrient® 400 mg film-coated tablets | Votrient 400 mg film-coated tablets Each film-coated tablet contains 400 mg pazopanib (as hydrochloride). For the full list of excipients, see section 6.1. | Film-coated tablet. Votrient 400 mg film-coated tablets Capsule-shaped, white, film-coated tablet with GS UHL debossed on one side. | Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1161 | Jan. 1, 2021 | Feb. 28, 2022 | See Details |
| 394 | Votrient® 200 mg film-coated tablets | Votrient 200 mg film-coated tablets Each film-coated tablet contains 200 mg pazopanib (as hydrochloride). | Film-coated tablet. Votrient 200 mg film-coated tablets Capsule-shaped, pink, film-coated tablet with GS JT debossed on one side. | Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1160 | Jan. 1, 2021 | Feb. 28, 2022 | See Details |
| 393 | Ultibro® Breezhaler® 85 micrograms/43 micrograms inhalation powder hard capsules | Each capsule contains 143 micrograms of indacaterol maleate equivalent to 110 micrograms of indacaterol and 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of glycopyrronium. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 110 micrograms of indacaterol maleate equivalent to 85 micrograms of indacaterol and 54 micrograms of glycopyrronium bromide equivalent to 43 micrograms of glycopyrronium. Excipient(s) with known effect Each capsule contains 23.5 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. | Inhalation powder, hard capsule (inhalation powder). Capsules with transparent yellow cap and natural transparent body containing a white to almost white powder, with the product code “IGP110.50” printed in blue under two blue bars on the body and the company logo ( ) printed in black on the cap. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1157 | Jan. 1, 2021 | Jan. 6, 2026 | See Details |
| 392 | Tyverb® 250 mg film-coated tablets | Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Oval, biconvex, yellow film-coated tablets, with “GS XJG” debossed on one side. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1156 | Jan. 1, 2021 | June 7, 2022 | See Details |
| 391 | TRAVATAN® 40 micrograms/mL eye drops, solution | Each mL of solution contains 40 micrograms of travoprost. Excipient(s) with known effect: Each mL of solution contains polyquaternium-1 (POLYQUAD) 10 microgram, propylene glycol 7.5 mg, polyoxyethylene hydrogenated castor oil 40 (HCO-40) 2 mg (see section 4.4.) For the full list of excipients, see section 6.1. | Eye drops, solution. (eye drops) Clear, colourless solution. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ | PLGB 00101/1155 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 390 | Tasigna® 50 mg hard capsules | One hard capsule contains 50 mg nilotinib (as hydrochloride monohydrate). Excipient with known effect One hard capsule contains 39.03 mg lactose monohydrate. | Hard capsule. White to yellowish powder in hard gelatin capsule with red opaque cap and light yellow opaque body, size 4 with black radial imprint “NVR/ABL” on cap. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1152 | Jan. 1, 2021 | Sept. 21, 2023 | See Details |
| 389 | ` Tasigna® 200 mg hard capsules | One hard capsule contains 200 mg nilotinib (as hydrochloride monohydrate). Excipient with known effect One hard capsule contains 156.11 mg lactose monohydrate. For the full list of excipients, see section 6.1. | Hard capsule. White to yellowish powder in light yellow opaque hard gelatin capsules, size 0 with red axial imprint “NVR/TKI”. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1151 | Jan. 1, 2021 | Sept. 21, 2023 | See Details |
| 388 | Tasigna® 150 mg hard capsules | One hard capsule contains 150 mg nilotinib (as hydrochloride monohydrate). Excipient with known effect One hard capsule contains 117.08 mg lactose monohydrate. For the full list of excipients, see section 6.1. | Hard capsule. White to yellowish powder in red opaque hard gelatin capsules, size 1 with black axial imprint “NVR/BCR”. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1150 | Jan. 1, 2021 | Sept. 21, 2023 | See Details |
| 387 | Tafinlar® 75 mg hard capsules | Tafinlar 75 mg hard capsules Each hard capsule contains dabrafenib mesilate equivalent to 75 mg of dabrafenib. For the full list of excipients, see section 6.1. | Hard capsule (capsule). Tafinlar 75 mg hard capsules Opaque dark pink capsules, approximately 19 mm long, with capsule shell imprinted with “GS LHF” and “75 mg”. | Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1149 | Jan. 1, 2021 | July 4, 2025 | See Details |
| 386 | Tafinlar® 50 mg hard capsules | Tafinlar 50 mg hard capsules Each hard capsule contains dabrafenib mesilate equivalent to 50 mg of dabrafenib. For the full list of excipients, see section 6.1. | Hard capsule (capsule). Tafinlar 50 mg hard capsules Opaque dark red capsules, approximately 18 mm long, with capsule shell imprinted with “GS TEW” and “50 mg”. | Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1148 | Jan. 1, 2021 | July 4, 2025 | See Details |
| 385 | Simulect® 20 mg powder and solvent for solution for injection or infusion | Each vial contains 20 mg basiliximab*. One ml of the reconstituted solution contains 4 mg basiliximab. * recombinant murine/human chimeric monoclonal antibody directed against the interleukin-2 receptor a-chain (CD25 antigen) produced in a mouse myeloma cell line by recombinant DNA technology. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection or infusion White powder | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1144 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 384 | Simulect® 10 mg powder and solvent for solution for injection or infusion | Each vial contains 10 mg basiliximab*. One ml of the reconstituted solution contains 4 mg basiliximab. * recombinant murine/human chimeric monoclonal antibody directed against the interleukin-2 receptor a-chain (CD25 antigen) produced in a mouse myeloma cell line by recombinant DNA technology. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection or infusion White powder | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1143 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 383 | SIMBRINZA 10 mg/mL + 2 mg/mL eye drops, suspension | 1 mL of suspension contains 10 mg of brinzolamide and 2 mg of brimonidine tartrate equivalent to 1.3 mg of brimonidine. Excipient with known effect Each mL of suspension contains 0.03 mg of benzalkonium chloride. For the full list of excipients, see section 6.1. | Eye drops, suspension (eye drops). White-to-off-white uniform suspension, pH 6.5 (approximately). | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ | PLGB 00101/1142 | Jan. 1, 2021 | July 17, 2023 | See Details |
| 382 | Seebri® Breezhaler® 44 micrograms inhalation powder, hard capsules | Each capsule contains 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of glycopyrronium. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 55 micrograms of glycopyrronium bromide equivalent to 44 micrograms of glycopyrronium. Excipient(s) with known effect: Each capsule contains 23.6 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. | Inhalation powder, hard capsule (inhalation powder). Transparent orange capsules containing a white powder, with the product code “GPL50” printed in black above and the company logo ( ) printed in black below a black bar. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom Blister Card Blister Inhaler base Inhaler Base Cap Side buttons Capsule chamber Mouthpiece Screen | PLGB 00101/1133 | Jan. 1, 2021 | July 25, 2022 | See Details |
| 381 | Rydapt® 25 mg soft capsules | Each soft capsule contains 25 mg midostaurin. Excipients with known effect Each soft capsule contains approximately 83 mg ethanol anhydrous and 415 mg macrogolglycerol hydroxystearate. For the full list of excipients, see section 6.1. | Soft capsule (capsule). Pale orange, oblong capsule with red imprint “PKC NVR”. The dimensions of the capsule are approximately 25.4 x 9.2 mm. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1130 | Jan. 24, 2024 | See Details | |
| 380 | Revolade® 75 mg film-coated tablets | Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg eltrombopag. For the full list of excipients, see section 6.1. | Film-coated tablet. Pink, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS FFS’ and ‘75’ on one side. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1129 | Jan. 1, 2021 | July 13, 2023 | See Details |
| 379 | Revolade® 50 mg film-coated tablets | Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag. For the full list of excipients, see section 6.1. | Film-coated tablet. Brown, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS UFU’ and ‘50’ on one side. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1128 | Jan. 1, 2021 | Jan. 8, 2026 | See Details |
| 378 | Revolade 25 mg powder for oral suspension | Each sachet contains eltrombopag olamine equivalent to 25 mg of eltrombopag. For the full list of excipients, see section 6.1. | Powder for oral suspension Reddish-brown to yellow powder. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1127 | Jan. 1, 2021 | Jan. 8, 2026 | See Details |
| 377 | Revolade® 25 mg film-coated tablets | Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag. For the full list of excipients, see section 6.1. | Film-coated tablet. White, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS NX3’ and ‘25’ on one side. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1126 | Jan. 1, 2021 | Jan. 8, 2026 | See Details |
| 376 | Revolade® 12.5 mg film-coated tablets | Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg eltrombopag. For the full list of excipients, see section 6.1. | Film-coated tablet. White, round, biconvex film-coated tablet (approximately 7.9 mm in diameter) debossed with ‘GS MZ1’ and ‘12.5’ on one side. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1125 | Jan. 1, 2021 | Jan. 8, 2026 | See Details |
| 375 | Prometax® 9.5 mg/24 h transdermal patch | Each transdermal patch releases 9.5 mg of rivastigmine per 24 hours. Each transdermal patch of 10 cm2 contains 18 mg of rivastigmine. For the full list of excipients, see section 6.1. | Transdermal patch Each transdermal patch is a thin, matrix-type transdermal patch consisting of three layers. The outside of the backing layer is beige and labelled with “Prometax”, “9.5 mg/24 h” and “BHDI”. | Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland | PLGB 00101/1124 | Jan. 1, 2021 | Sept. 23, 2025 | See Details |
| 374 | Prometax® 4.6 mg/24 h transdermal patch | Each transdermal patch releases 4.6 mg of rivastigmine per 24 hours. Each transdermal patch of 5 cm2 contains 9 mg of rivastigmine. For the full list of excipients, see section 6.1. | Transdermal patch Each transdermal patch is a thin, matrix-type transdermal patch consisting of three layers. The outside of the backing layer is beige and labelled with “Prometax”, “4.6 mg/24 h” and “AMCX”. | Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland | PLGB 00101/1123 | Jan. 1, 2021 | Sept. 23, 2025 | See Details |
| 373 | Prometax® 13.3 mg/24 h transdermal patch | Each transdermal patch releases 13.3 mg of rivastigmine per 24 hours. Each transdermal patch of 15 cm2 contains 27 mg of rivastigmine. For the full list of excipients, see section 6.1. | Transdermal patch Each transdermal patch is a thin, matrix-type transdermal patch consisting of three layers. The outside of the backing layer is beige and labelled with “Prometax”, “13.3 mg/24 h” and “CNFU”. | Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland | PLGB 00101/1122 | Jan. 1, 2021 | Sept. 23, 2025 | See Details |
| 372 | Prometax 2 mg/ml oral solution | Each ml contains rivastigmine hydrogen tartrate corresponding to 2 mg rivastigmine. Excipient(s) with known effect Each 3 ml oral solution contains 3 mg of sodium benzoate (E211). For the full list of excipients, see section 6.1. | Oral solution Clear, yellow solution. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1121 | Jan. 1, 2021 | Sept. 23, 2025 | See Details |
| 371 | Prometax 6.0 mg hard capsules | Each capsule contains rivastigmine hydrogen tartrate corresponding to 6.0 mg rivastigmine. For the full list of excipients, see section 6.1. | Hard capsules Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “ENA 713 6 mg” on body. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1120 | Jan. 1, 2021 | Oct. 20, 2023 | See Details |
| 370 | Prometax 4.5 mg hard capsules | Each capsule contains rivastigmine hydrogen tartrate corresponding to 4.5 mg rivastigmine. For the full list of excipients, see section 6.1. | Hard capsules Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “ENA 713 4,5 mg” on body. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1119 | Jan. 1, 2021 | Sept. 23, 2025 | See Details |
| 369 | Prometax 3.0 mg hard capsules | Each capsule contains rivastigmine hydrogen tartrate corresponding to 3.0 mg rivastigmine. For the full list of excipients, see section 6.1. | Hard capsules Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint “ENA 713 3 mg” on body. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1118 | Jan. 1, 2021 | Sept. 23, 2025 | See Details |
| 368 | Prometax 1.5 mg hard capsules | Each capsule contains rivastigmine hydrogen tartrate corresponding to 1.5 mg rivastigmine. For the full list of excipients, see section 6.1. | Hard capsules Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “ENA 713 1,5 mg” on body. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1117 | Jan. 1, 2021 | Sept. 23, 2025 | See Details |
| 367 | Opatanol® 1 mg/mL eye drops, solution | One mL of solution contains 1 mg olopatadine (as hydrochloride). Excipient(s) with known effect: Benzalkonium chloride 0.1 mg/ml. Disodium phosphate dodecahydrate (E339) 12.61 mg/ml (equivalent to 3.34 mg/ml of phosphates). For the full list of excipients, see section 6.1. | Eye drops, solution (eye drops). Clear, colourless solution. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ | PLGB 00101/1114 | Jan. 1, 2021 | Dec. 20, 2022 | See Details |
| 366 | Onbrez® Breezhaler® 300 microgram inhalation powder, hard capsules | Onbrez Breezhaler 300 microgram inhalation powder, hard capsules: Each capsule contains indacaterol maleate equivalent to 300 microgram indacaterol. The delivered dose leaving the mouthpiece of the inhaler is indacaterol maleate equivalent to 240 microgram indacaterol. Excipient with known effect Each capsule contains 24.6 mg lactose. For the full list of excipients, see section 6.1. | Inhalation powder, hard capsule Onbrez Breezhaler 300 microgram inhalation powder, hard capsules: Transparent (uncoloured) capsules containing a white powder, with “IDL 300” printed in blue above a blue bar and company logo ( ) printed in blue below the blue bar. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1113 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 365 | Onbrez® Breezhaler® 150 microgram inhalation powder, hard capsules | Onbrez Breezhaler 150 microgram inhalation powder, hard capsules: Each capsule contains indacaterol maleate equivalent to 150 microgram indacaterol. The delivered dose leaving the mouthpiece of the inhaler is indacaterol maleate equivalent to 120 microgram indacaterol. Excipient with known effect Each capsule contains 24.8 mg lactose. For the full list of excipients, see section 6.1. | Inhalation powder, hard capsule Onbrez Breezhaler 150 microgram inhalation powder, hard capsules: Transparent (uncoloured) capsules containing a white powder, with “IDL 150” printed in black above a black bar and company logo ( ) printed in black below the black bar. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1112 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 364 | NEVANAC® 3 mg/ml eye drops, suspension | 1 ml of suspension contains 3 mg nepafenac. Excipient with known effect Each ml of suspension contains 0.05 mg benzalkonium chloride For the full list of excipients, see section 6.1. | Eye drops, suspension Light yellow to dark orange uniform suspension, pH 6.8 (approximately). | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ | PLGB 00101/1111 | Jan. 1, 2021 | May 20, 2024 | See Details |
| 363 | NEVANAC® 1 mg/ml eye drops, suspension | 1 ml of suspension contains 1 mg nepafenac. Excipient with known effect Each ml of suspension contains 0.05 mg of benzalkonium chloride. For the full list of excipients, see section 6.1. | Eye drops, suspension Light yellow to light orange uniform suspension, pH 7.4 (approximately). | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ | PLGB 00101/1110 | Jan. 1, 2021 | May 20, 2024 | See Details |
| 362 | Mekinist® 2 mg film-coated tablets | Mekinist 0.5 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg of trametinib. Mekinist 2 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 2 mg of trametinib. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet) Mekinist 0.5 mg film-coated tablets Yellow, modified oval, biconvex, film-coated tablets, approximately 5.0 x 9.0 mm, with the company logo debossed on one face and “TT” on the opposing face. Mekinist 2 mg film-coated tablets Pink, round, biconvex, film-coated tablets, approximately 7.6 mm, with the company logo debossed on one face and “LL” on the opposing face. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ | PLGB 00101/1106 | Jan. 1, 2021 | Nov. 20, 2024 | See Details |
| 361 | Mekinist® 0.5 mg film-coated tablets | Mekinist 0.5 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg of trametinib. Mekinist 2 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 2 mg of trametinib. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet) Mekinist 0.5 mg film-coated tablets Yellow, modified oval, biconvex, film-coated tablets, approximately 5.0 x 9.0 mm, with the company logo debossed on one face and “TT” on the opposing face. Mekinist 2 mg film-coated tablets Pink, round, biconvex, film-coated tablets, approximately 7.6 mm, with the company logo debossed on one face and “LL” on the opposing face. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ | PLGB 00101/1105 | Jan. 1, 2021 | Nov. 20, 2024 | See Details |
| 360 | Luxturna® 5 x 1012 vector genomes/mL concentrate and solvent for solution for injection | General description Voretigene neparvovec is a gene transfer vector that employs an adeno-associated viral vector serotype 2 (AAV2) capsid as a delivery vehicle for the human retinal pigment epithelium 65 kDa protein (hRPE65) cDNA to the retina. Voretigene neparvovec is derived from wild-type AAV2 using recombinant DNA techniques. Each mL of concentrate contains 5 × 1012 vector genomes (vg). Each vial of Luxturna contains 0.5 extractable mL of concentrate (corresponding to 2.5 × 1012 vector genomes) which requires a 1:10 dilution prior to administration, see section 6.6. After dilution of 0.3 mL of concentrate with 2.7 mL of solvent, each mL contains 5 × 1011 vector genomes. Each dose of 0.3 mL Luxturna contains 1.5 x 1011 vector genomes. For the full list of excipients, see section 6.1. | Concentrate and solvent for solution for injection. Following thaw from their frozen state, both the concentrate and the solvent are clear, colourless liquids with a pH of 7.3. | and product should not be used. Transfer 2.7 mL of solvent taken from the two thawed vials and dispense into a sterile 10 mL empty glass vial using a 3 mL syringe. For dilution, draw 0.3 mL of thawed concentrate into a 1 mL syringe and add it to the 10 mL sterile vial containing the solvent. Gently invert the vial at least five times for proper mixing. Inspect for any visual particulates. The diluted solution should be clear to slightly opalescent. Label the 10 mL glass vial containing the diluted concentrate as follows: ‘Diluted Luxturna’. Do not prepare syringes if the vial shows any damage or if any visual particulates are observed. Prepare the syringes for injection by drawing 0.8 mL of the diluted solution into a sterile 1 mL syringe. Repeat the same procedure to prepare a backup syringe. The product-filled syringes should then be transferred in a designated transport container to the surgical suite. Measures to take in case of accidental exposure Accidental exposure must be avoided. Local biosafety guidelines for preparation, administration and handling of voretigene neparvovec should be followed. • Personal protective equipment (to include laboratory coat, safety glasses and gloves) should be worn while handling or administering voretigene neparvovec. • Accidental exposure to voretigene neparvovec, including contact with skin, eyes and mucous membranes, is to be avoided. Any exposed wounds should be covered before handling. • All spills of voretigene neparvovec must be treated with a virucidal agent such as 1% sodium hypochlorite and blot using absorbent materials. • All materials that may have come in contact with voretigene neparvovec (e.g. vial, syringe, needle, cotton gauze, gloves, masks or dressings) must be disposed of in accordance with local biosafety guidelines. Accidental exposure • In the event of an accidental occupational exposure (e.g. through a splash to the eyes or mucous membranes), flush with clean water for at least 5 minutes. • In the event of exposure to broken skin or needlestick injury, clean the affected area thoroughly with soap and water and/or a disinfectant. Precautions to be taken for the disposal of the medicinal product This medicinal product contains genetically modified organisms. Unused medicinal product or waste material must be disposed of in compliance with the local guidance for pharmaceutical waste. Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ | PLGB 00101/1104 | July 24, 2023 | June 20, 2024 | See Details |
| 359 | Lucentis® 10 mg/ml solution for injection in pre-filled syringe | One ml contains 10 mg ranibizumab*. One pre-filled syringe contains 0.165 ml, equivalent to 1.65 mg ranibizumab. The extractable volume of one pre-filled syringe is 0.1 ml. This provides a usable amount to deliver a single dose of 0.05 ml containing 0.5 mg ranibizumab. *Ranibizumab is a humanised monoclonal antibody fragment produced in Escherichia coli cells by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection. Clear, colourless to pale brownish-yellow aqueous solution. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1103 | Jan. 1, 2021 | July 17, 2023 | See Details |
| 358 | Lucentis® 10 mg/ml solution for injection | One ml contains 10 mg ranibizumab*. Each vial contains 2.3 mg of ranibizumab in 0.23 ml solution. This provides a usable amount to deliver a single dose of 0.05 ml containing 0.5 mg ranibizumab to adult patients and a single dose of 0.02 ml containing 0.2 mg ranibizumab to preterm infants. *Ranibizumab is a humanised monoclonal antibody fragment produced in Escherichia coli cells by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection. Clear, colourless to pale brownish-yellow aqueous solution. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1102 | Jan. 1, 2021 | July 17, 2023 | See Details |
| 357 | Kymriah 1.2 × 106 – 6 × 108 cells dispersion for infusion | 2.1 General description Kymriah (tisagenlecleucel) is a genetically modified autologous cell-based product containing T cells transduced ex vivo using a lentiviral vector expressing an anti-CD19 chimeric antigen receptor (CAR) comprising a murine anti-CD19 single chain variable fragment (scFv) linked via a human CD8 hinge and transmembrane region to an intracellular signalling chain of human 4-1BB (CD137) co-stimulatory domain and CD3-zeta signalling domain. 2. Each patient-specific infusion bag of Kymriah contains tisagenlecleucel at a batch-dependent concentration of autologous T cells genetically modified to express an anti-CD19 chimeric antigen receptor (CAR-positive viable T cells). The medicinal product is packaged in one or more infusion bags overall containing a cell dispersion of 1.2 × 106 to 6 × 108 CAR-positive viable T cells in a cryopreservative solution. The cellular composition and the final cell number varies between individual patient batches. In addition to T cells, natural killer (NK) cells may be present. Each infusion bag contains 10-30 mL or 30-50 mL of cell dispersion. The quantitative information of medicinal product, including the number of infusion bags (see section 6) to be administered, is presented on the batch-specific documentation accompanying the medicinal product for treatment. Excipients with known effect This medicinal product contains 2.43 mg sodium per mL and 24.3 to 121.5 mg sodium per dose. Each bag contains 11 mg dextran 40 and 82.5 mg dimethyl sulfoxide (DMSO) per mL. For the full list of excipients, see section 6.1. | Dispersion for infusion A colourless to slightly yellow dispersion | Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ | PLGB 00101/1101 | July 15, 2025 | See Details | |
| 356 | Kisqali® 200 mg film-coated tablets | Each film-coated tablet contains ribociclib succinate, equivalent to 200 mg ribociclib. Excipients with known effect Each film-coated tablet contains 0.344 mg soya lecithin. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Light greyish violet, unscored, round, curved with bevelled edges (approximate diameter: 11.1 mm), debossed with “RIC” on one side and “NVR” on the other side. | Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ | PLGB 00101/1100 | Aug. 8, 2022 | Dec. 29, 2025 | See Details |
| 355 | Jakavi® 5 mg tablets | Jakavi 5 mg tablets Each tablet contains 5 mg ruxolitinib (as phosphate). Excipient with known effect Each tablet contains 71.45 mg lactose monohydrate. For the full list of excipients, see section 6.1. | Tablet. Jakavi 5 mg tablets Round curved white to almost white tablets of approximately 7.5 mm in diameter with “NVR” debossed on one side and “L5” debossed on the other side. | Novartis Pharmaceuticals UK Limited 2nd Floor, West Works Building, White City place, 195 Wood Lane W12 7FQ UK | PLGB 00101/1098 | Jan. 1, 2021 | July 14, 2025 | See Details |
| 354 | Jakavi® 20 mg tablets | Jakavi 20 mg tablets Each tablet contains 20 mg ruxolitinib (as phosphate). Excipient with known effect Each tablet contains 285.80 mg lactose monohydrate. For the full list of excipients, see section 6.1. | Tablet. Jakavi 20 mg tablets Elongated curved white to almost white tablets of approximately 16.5 x 7.4 mm with “NVR” debossed one one side and “L20” debossed on the other side. | Novartis Pharmaceuticals UK Limited 2nd Floor, West Works Building, White City place, 195 Wood Lane W12 7FQ UK | PLGB 00101/1097 | Jan. 1, 2021 | July 14, 2025 | See Details |
| 353 | Jakavi® 15 mg tablets | Jakavi 15 mg tablets Each tablet contains 15 mg ruxolitinib (as phosphate). Excipient with known effect Each tablet contains 214.35 mg lactose monohydrate. For the full list of excipients, see section 6.1. | Tablet. Jakavi 15 mg tablets Ovaloid curved white to almost white tablets of approximately 15.0 x 7.0 mm with “NVR” debossed on one side and “L15” debossed on the other side. | Novartis Pharmaceuticals UK Limited 2nd Floor, West Works Building, White City place, 195 Wood Lane W12 7FQ UK | PLGB 00101/1096 | Jan. 1, 2021 | July 14, 2025 | See Details |
| 352 | Jakavi® 10 mg tablets | Jakavi 10 mg tablets Each tablet contains 10 mg ruxolitinib (as phosphate). Excipient with known effect Each tablet contains 142.90 mg lactose monohydrate. For the full list of excipients, see section 6.1. | Tablet. Jakavi 10 mg tablets Round curved white to almost white tablets of approximately 9.3 mm in diameter with “NVR” debossed on one side and “L10” debossed on the other side. | Novartis Pharmaceuticals UK Limited 2nd Floor, West Works Building, White City place, 195 Wood Lane W12 7FQ UK | PLGB 00101/1095 | Jan. 1, 2021 | July 14, 2025 | See Details |
| 351 | Ilaris 150 mg/ml solution for injection | Each vial contains 150 mg canakinumab in 1 ml. Canakinumab is a human monoclonal antibody produced in mouse myeloma Sp2/0 cells by recombinant DNA technology. Excipient with known effect The solution for injection contains 0.4 mg/ml polysorbate 80. For the full list of excipients, see section 6.1. | Solution for injection (injection). The solution is clear to opalescent and colourless to slightly brownish yellow with a pH of approximately 6.5 and osmolality of 350 to 450 mOsm/kg. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1093 | Jan. 1, 2021 | See Details | |
| 350 | Ilaris 150 mg powder for solution for injection | Each vial contains 150 mg of canakinumab. After reconstitution, each ml of solution contains 150 mg canakinumab. Canakinumab is a human monoclonal antibody produced in mouse myeloma Sp2/0 cells by recombinant DNA technology. Excipient with known effect Each vial contains 0.6 mg polysorbate 80. For the full list of excipients, see section 6.1. | Powder for solution for injection. The powder is white. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1092 | Jan. 1, 2021 | See Details | |
| 349 | Glivec® 100 mg film-coated tablets Glivec® 400 mg film-coated tablets | Each film-coated tablet contains 400 mg imatinib (as mesilate). For the full list of excipients, see section 6.1. | Film-coated tablet Glivec 100 mg film-coated tablets Very dark yellow to brownish-orange film-coated tablet, round with “NVR” on one side and “SA” and score on the other side. Glivec 400 mg film-coated tablets Very dark yellow to brownish-orange, ovaloid, biconvex film-coated tablet with bevelled edges. Debossed with “400” on one side and score on the other side with “SL” on each side of the score. The film-coated tablets can be divided into equal doses. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1081 | Jan. 1, 2021 | Jan. 27, 2026 | See Details |
| 348 | Glivec® 100 mg film-coated tablets Glivec® 400 mg film-coated tablets | Each film-coated tablet contains 100 mg imatinib (as mesilate). For the full list of excipients, see section 6.1. | Film-coated tablet Very dark yellow to brownish-orange film-coated tablet, round with “NVR” on one side and “SA” and score on the other side. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1080 | Jan. 1, 2021 | Jan. 27, 2026 | See Details |
| 347 | Glivec® 100 mg hard capsules | Each capsule contains 100 mg imatinib (as mesilate). For the full list of excipients, see section 6.1. | Hard capsule White to yellow powder in an orange to greyish-orange opaque capsule, marked “NVR SI”. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1079 | Jan. 1, 2021 | Jan. 3, 2024 | See Details |
| 346 | Gilenya® 0.25 mg hard capsules Gilenya® 0.5 mg hard capsules | Each 0.5 mg capsule contains 0.5 mg fingolimod (as hydrochloride). For the full list of excipients, see section 6.1. | Hard capsule Capsule of 16 mm with bright yellow opaque cap and white opaque body; imprint with black ink, “FTY0.5 mg” on cap and two radial bands imprinted on the body with yellow ink. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1078 | Jan. 1, 2021 | March 11, 2025 | See Details |
| 345 | Gilenya® 0.25 mg hard capsules Gilenya® 0.5 mg hard capsules | Each 0.25 mg capsule contains 0.25 mg fingolimod (as hydrochloride). For the full list of excipients, see section 6.1. | Hard capsule Capsule of 16 mm with ivory opaque cap and body, with black radial imprint “FTY 0.25mg” on cap and black radial band on body. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1077 | Jan. 1, 2021 | March 11, 2025 | See Details |
| 344 | Extavia® 250 microgram/ml powder and solvent for solution for injection. | Extavia contains 300 microgram (9.6 million IU) of recombinant interferon beta-1b per vial*. After reconstitution, each ml contains 250 microgram (8.0 million IU) of recombinant interferon beta-1b. * produced by genetic engineering from strain of Escherichia coli. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. Powder - white to off-white in colour. Solvent - clear/colourless solution. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ | PLGB 00101/1072 | Jan. 1, 2021 | Aug. 24, 2023 | See Details |
| 343 | EXJADE® 90 mg granules in sachet | EXJADE 90 mg granules Each sachet contains 90 mg deferasirox. For the full list of excipients, see section 6.1. | Granules in sachet (granules) White to almost white granules | Novartis Pharmaceuticals UK Limited 2nd Floor, West Works Building White City Place 195 Wood Lane London, W12 7FQ | PLGB 00101/1071 | Jan. 1, 2021 | May 31, 2023 | See Details |
| 342 | EXJADE® 90 mg film-coated tablets | EXJADE 90 mg film-coated tablets Each film-coated tablet contains 90 mg deferasirox. | Film-coated tablet EXJADE 90 mg film-coated tablets Light blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 90 on the other). Approximate tablet dimensions 10.7 mm x 4.2 mm. | Novartis Pharmaceuticals UK Limited 2nd Floor, West Works Building White City Place 195 Wood Lane London, W12 7FQ | PLGB 00101/1070 | Jan. 1, 2021 | May 31, 2023 | See Details |
| 341 | EXJADE® 250 mg dispersible tablets | EXJADE 500 mg dispersible tablets Each dispersible tablet contains 500 mg deferasirox. Excipient with known effect: Each dispersible tablet contains 544 mg lactose. For the full list of excipients, see section 6.1. | Dispersible tablet EXJADE 500 mg dispersible tablets White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 500 on the other). Approximate tablet dimensions 20 mm x 5.6 mm. | Novartis Pharmaceuticals UK Limited 2nd Floor, West Works Building White City Place 195 Wood Lane London, W12 7FQ | PLGB 00101/1069 | Jan. 1, 2021 | Feb. 7, 2022 | See Details |
| 340 | EXJADE® 360 mg granules in sachet | EXJADE 360 mg granules Each sachet contains 360 mg deferasirox. For the full list of excipients, see section 6.1. | Granules in sachet (granules) White to almost white granules | Novartis Pharmaceuticals UK Limited 2nd Floor, West Works Building White City Place 195 Wood Lane London, W12 7FQ | PLGB 00101/1068 | Jan. 1, 2021 | May 31, 2023 | See Details |
| 339 | EXJADE® 360 mg film-coated tablets | EXJADE 360 mg film-coated tablets Each film-coated tablet contains 360 mg deferasirox. | Film-coated tablet EXJADE 360 mg film-coated tablets Dark blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 360 on the other). Approximate tablet dimensions 17 mm x 6.7 mm. | Novartis Pharmaceuticals UK Limited 2nd Floor, West Works Building White City Place 195 Wood Lane London, W12 7FQ | PLGB 00101/1067 | Jan. 1, 2021 | May 31, 2023 | See Details |
| 338 | EXJADE® 250 mg dispersible tablets | EXJADE 250 mg dispersible tablets Each dispersible tablet contains 250 mg deferasirox. Excipient with known effect: Each dispersible tablet contains 272 mg lactose. For the full list of excipients, see section 6.1. | Dispersible tablet EXJADE 250 mg dispersible tablets White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 250 on the other). Approximate tablet dimensions 15 mm x 4.7 mm. | Novartis Pharmaceuticals UK Limited 2nd Floor, West Works Building White City Place 195 Wood Lane London, W12 7FQ | PLGB 00101/1066 | Jan. 1, 2021 | Feb. 7, 2022 | See Details |
| 337 | EXJADE® 180 mg granules in sachet | EXJADE 180 mg granules Each sachet contains 180 mg deferasirox. For the full list of excipients, see section 6.1. | Granules in sachet (granules) White to almost white granules | Novartis Pharmaceuticals UK Limited 2nd Floor, West Works Building White City Place 195 Wood Lane London, W12 7FQ | PLGB 00101/1065 | Jan. 1, 2021 | May 31, 2023 | See Details |
| 336 | EXJADE® 180 mg film-coated tablets | EXJADE 180 mg film-coated tablets Each film-coated tablet contains 180 mg deferasirox. | Film-coated tablet EXJADE 180 mg film-coated tablets Medium blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 180 on the other). Approximate tablet dimensions 14 mm x 5.5 mm. | Novartis Pharmaceuticals UK Limited 2nd Floor, West Works Building White City Place 195 Wood Lane London, W12 7FQ | PLGB 00101/1067 | Jan. 1, 2021 | May 31, 2023 | See Details |
| 335 | EXJADE® 125 mg dispersible tablets | EXJADE 125 mg dispersible tablets Each dispersible tablet contains 125 mg deferasirox. Excipient with known effect: Each dispersible tablet contains 136 mg lactose. For the full list of excipients, see section 6.1. | Dispersible tablet EXJADE 125 mg dispersible tablets White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 125 on the other). Approximate tablet dimensions 12 mm x 3.6 mm. | Novartis Pharmaceuticals UK Limited 2nd Floor, West Works Building White City Place 195 Wood Lane London, W12 7FQ | PLGB 00101/1063 | Jan. 1, 2021 | Feb. 7, 2022 | See Details |
| 334 | Exforge® 5 mg/80 mg film-coated tablets | Exforge 5 mg/80 mg film-coated tablets Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 80 mg of valsartan. For the full list of excipients, see section 6.1. | Film-coated tablet Exforge 5 mg/80 mg film-coated tablets Dark yellow, round film-coated tablet with bevelled edges, imprinted with “NVR” on one side and “NV” on the other side. Approximate size: diameter 8.20 mm. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1057 | Jan. 1, 2021 | April 25, 2025 | See Details |
| 333 | Exforge® 5 mg/160 mg film-coated tablets | Exforge 5 mg/160 mg film-coated tablets Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan. For the full list of excipients, see section 6.1. | Film-coated tablet Exforge 5 mg/160 mg film-coated tablets Dark yellow, oval film-coated tablet, imprinted with “NVR” on one side and “ECE” on the other side. Approximate size: 14.2 mm (length) x 5.7 mm (width). | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1056 | Jan. 1, 2021 | April 25, 2025 | See Details |
| 332 | Exforge® 10 mg/160 mg film-coated tablets | Exforge 10 mg/160 mg film-coated tablets Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan. For the full list of excipients, see section 6.1. | Film-coated tablet Exforge 10 mg/160 mg film-coated tablets Light yellow, oval film-coated tablet, imprinted with “NVR” on one side and “UIC” on the other side. Approximate size: 14.2 mm (length) x 5.7 mm (width). | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1055 | Jan. 1, 2021 | April 25, 2025 | See Details |
| 331 | Exelon® 9.5 mg/24 h transdermal patch | Exelon 9.5 mg/24 h transdermal patch Each transdermal patch releases 9.5 mg of rivastigmine per 24 hours. Each transdermal patch of 10 cm2 contains 18 mg of rivastigmine. For the full list of excipients, see section 6.1. | Transdermal patch Exelon 9.5 mg/24 h transdermal patch Each transdermal patch is a thin, matrix-type transdermal patch consisting of three layers. The outside of the backing layer is beige and labelled with “Exelon”, “9.5 mg/24 h” and “BHDI”. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1054 | Jan. 1, 2021 | Sept. 23, 2025 | See Details |
| 330 | Exelon® 4.6 mg/24 h transdermal patch | Exelon 4.6 mg/24 h transdermal patch Each transdermal patch releases 4.6 mg of rivastigmine per 24 hours. Each transdermal patch of 5 cm2 contains 9 mg of rivastigmine. For the full list of excipients, see section 6.1. | Transdermal patch Exelon 4.6 mg/24 h transdermal patch Each transdermal patch is a thin, matrix-type transdermal patch consisting of three layers. The outside of the backing layer is beige and labelled with “Exelon”, “4.6 mg/24 h” and “AMCX”. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1053 | Jan. 1, 2021 | Sept. 23, 2025 | See Details |
| 329 | Exelon® 13.3 mg/24 h transdermal patch | Exelon 13.3 mg/24 h transdermal patch Each transdermal patch releases 13.3 mg of rivastigmine per 24 hours. Each transdermal patch of 15 cm2 contains 27 mg of rivastigmine. For the full list of excipients, see section 6.1. | Transdermal patch Exelon 13.3 mg/24 h transdermal patch Each transdermal patch is a thin, matrix-type transdermal patch consisting of three layers. The outside of the backing layer is beige and labelled with “Exelon”, “13.3 mg/24 h” and “CNFU”. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1052 | Jan. 1, 2021 | Sept. 23, 2025 | See Details |
| 328 | Exelon 2 mg/ml oral solution | Each ml contains rivastigmine hydrogen tartrate corresponding to 2 mg rivastigmine. Excipient(s) with known effect Each 3 ml oral solution contains 3 mg of sodium benzoate (E211). For the full list of excipients, see section 6.1. | Oral solution Clear, yellow solution | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1051 | Jan. 1, 2021 | Sept. 23, 2025 | See Details |
| 327 | Exelon 6.0 mg hard capsules | Exelon 6.0 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 6.0 mg rivastigmine. For the full list of excipients, see section 6.1. | Hard capsules Exelon 6.0 mg hard capsules Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “EXELON 6 mg” on body. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1050 | Jan. 1, 2021 | Oct. 20, 2023 | See Details |
| 326 | Exelon 4.5 mg hard capsules | Exelon 4.5 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 4.5 mg rivastigmine. For the full list of excipients, see section 6.1. | Hard capsules Exelon 4.5 mg hard capsules Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “EXELON 4,5 mg” on body. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1049 | Jan. 1, 2021 | Sept. 23, 2025 | See Details |
| 325 | Exelon 3.0 mg hard capsules | Exelon 3.0 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 3.0 mg rivastigmine. For the full list of excipients, see section 6.1. | Hard capsules Exelon 3.0 mg hard capsules Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint “EXELON 3 mg” on body. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1048 | Jan. 1, 2021 | Oct. 20, 2023 | See Details |
| 324 | Exelon 1.5 mg hard capsules | Exelon 1.5 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 1.5 mg rivastigmine. For the full list of excipients, see section 6.1. | Hard capsules Exelon 1.5 mg hard capsules Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “EXELON 1,5 mg” on body. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1047 | Jan. 1, 2021 | Sept. 23, 2025 | See Details |
| 323 | Eucreas® 50 mg/850 mg film-coated tablets | Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin). For the full list of excipients, see section 6.1. | Film-coated tablet. Yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “SEH” on the other side. | Novartis Pharmaceuticals UK Limited 2nd Floor, West Works Building White City Place 195 Wood Lane London, W12 7FQ | PLGB 00101/1046 | Jan. 1, 2021 | July 24, 2025 | See Details |
| 322 | Eucreas® 50 mg/1000 mg film-coated tablets | Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformin). For the full list of excipients, see section 6.1. | Film-coated tablet. Dark yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “FLO” on the other side. | Novartis Pharmaceuticals UK Limited 2nd Floor, West Works Building White City Place 195 Wood Lane London, W12 7FQ | PLGB 00101/1045 | Jan. 1, 2021 | July 24, 2025 | See Details |
| 321 | Entresto® 97 mg/103 mg film-coated tablets | Each film-coated tablet contains 97.2 mg sacubitril and 102.8 mg valsartan (as sacubitril valsartan sodium salt complex). For the full list of excipients, see section 6.1. | Film-coated tablet (tablet) Light pink ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “L11” on the other side. Approximate tablet dimensions 15.1 mm x 6.0 mm. | Novartis Pharmaceuticals UK Limited 2nd Floor, West Works Building White City Place 195 Wood Lane London, W12 7FQ | PLGB 00101/1043 | Jan. 1, 2021 | Sept. 15, 2025 | See Details |
| 320 | Entresto® 49 mg/51 mg film-coated tablets | Each film-coated tablet contains 48.6 mg sacubitril and 51.4 mg valsartan (as sacubitril valsartan sodium salt complex). For the full list of excipients, see section 6.1. | Film-coated tablet (tablet) Pale yellow ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “L1” on the other side. Approximate tablet dimensions 13.1 mm x 5.2 mm. | Novartis Pharmaceuticals UK Limited 2nd Floor, West Works Building White City Place 195 Wood Lane London, W12 7FQ | PLGB 00101/1042 | Jan. 1, 2021 | Sept. 15, 2025 | See Details |
| 319 | Entresto® 24 mg/26 mg film-coated tablets | Each film-coated tablet contains 24.3 mg sacubitril and 25.7 mg valsartan (as sacubitril valsartan sodium salt complex). For the full list of excipients, see section 6.1. | Film-coated tablet (tablet) Violet white ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “LZ” on the other side. Approximate tablet dimensions 13.1 mm x 5.2 mm. | Novartis Pharmaceuticals UK Limited 2nd Floor, West Works Building White City Place 195 Wood Lane London, W12 7FQ | PLGB 00101/1041 | Jan. 1, 2021 | Sept. 15, 2025 | See Details |
| 318 | DuoTrav 40 micrograms/mL + 5 mg/mL eye drops, solution | Each mL of solution contains 40 micrograms of travoprost and 5 mg of timolol (as timolol maleate). Excipient(s) with known effect Each mL of solution contains polyquaternium-1 (POLYQUAD) 10 microgram, propylene glycol 7.5 mg and polyoxyethylene hydrogenated castor oil 40 1 mg (see section 4.4). For the full list of excipients, see section 6.1. | Eye drops, solution (eye drops). Clear, colourless solution. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ | PLGB 00101/1039 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 317 | Cosentyx 150 mg solution for injection in pre-filled syringe | Cosentyx 150 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 150 mg secukinumab in 1 ml. Secukinumab is a recombinant fully human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells. For the full list of excipients, see section 6.1. | Solution for injection (injection) The solution is clear and colourless to slightly yellow. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1030 | Jan. 1, 2021 | Aug. 5, 2025 | See Details |
| 316 | Cosentyx 150 mg solution for injection in pre-filled pen | Cosentyx 150 mg solution for injection in pre-filled pen Each pre-filled pen contains 150 mg secukinumab in 1 ml. Secukinumab is a recombinant fully human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells. For the full list of excipients, see section 6.1. | Solution for injection (injection) The solution is clear and colourless to slightly yellow. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1029 | Jan. 1, 2021 | Aug. 5, 2025 | See Details |
| 315 | Cosentyx 150 mg powder for solution for injection | Each vial of powder contains 150 mg secukinumab. After reconstitution, 1 ml of solution contains 150 mg secukinumab. Secukinumab is a recombinant fully human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells. For the full list of excipients, see section 6.1. | Powder for solution for injection The powder is a white solid lyophilisate. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1028 | Jan. 1, 2021 | Aug. 5, 2025 | See Details |
| 314 | AZOPT 10 mg/ml eye drops, suspension | Each ml of suspension contains 10 mg brinzolamide. Excipient with known effect: Each ml of suspension contains 0.1 mg benzalkonium chloride. For a full list of excipients, see section 6.1. | Eye drops, suspension. White to off-white suspension. | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ United Kingdom | PLGB 00101/1018 | Jan. 1, 2021 | Aug. 23, 2023 | See Details |
| 313 | AZARGA 10 mg/ml + 5 mg/ml eye drops, suspension | One ml of suspension contains 10 mg brinzolamide and 5 mg timolol (as timolol maleate). Excipient with known effect: One ml of suspension contains 0.10 mg benzalkonium chloride. For the full list of excipients, see section 6.1. | Eye drops, suspension (eye drops) White to off-white uniform suspension, pH 7.2 (approximately). | Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place 195 Wood Lane London W12 7FQ | PLGB 00101/1017 | Jan. 1, 2021 | May 5, 2023 | See Details |
| 312 | Afinitor® 5 mg tablets | Afinitor 5 mg tablets Each tablet contains 5 mg everolimus. Excipient with known effect Each tablet contains 149 mg lactose. For the full list of excipients, see section 6.1. | Tablet. Afinitor 5 mg tablets White to slightly yellow, elongated tablets of approximately 12.1 mm in length and 4.9 mm in width, with a bevelled edge and no score, engraved with “5” on one side and “NVR” on the other. | Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1014 | Jan. 1, 2021 | July 12, 2022 | See Details |
| 311 | Afinitor® 2.5 mg tablets | Afinitor 2.5 mg tablets Each tablet contains 2.5 mg everolimus. Excipient with known effect Each tablet contains 74 mg lactose. For the full list of excipients, see section 6.1. | Tablet. Afinitor 2.5 mg tablets White to slightly yellow, elongated tablets of approximately 10.1 mm in length and 4.1 mm in width, with a bevelled edge and no score, engraved with “LCL” on one side and “NVR” on the other. | Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1013 | Jan. 1, 2021 | July 12, 2022 | See Details |
| 310 | Afinitor® 10 mg tablets | Afinitor 10 mg tablets Each tablet contains 10 mg everolimus. Excipient with known effect Each tablet contains 297 mg lactose. For the full list of excipients, see section 6.1. | Tablet. Afinitor 10 mg tablets White to slightly yellow, elongated tablets of approximately 15.1 mm in length and 6.0 mm in width, with a bevelled edge and no score, engraved with “UHE” on one side and “NVR” on the other. | Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ United Kingdom | PLGB 00101/1012 | Jan. 1, 2021 | July 12, 2022 | See Details |
| 309 | Talzenna 0.1 mg hard capsules | Each hard capsule contains talazoparib tosylate equivalent to 0.1 mg talazoparib. For the full list of excipients, see section 6.1. | Hard capsule (capsule). Opaque, approximately 14 mm × 5 mm hard capsule with a white cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.1” in black). | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | PLGB 00057/1726 | April 11, 2024 | June 25, 2025 | See Details |
| 308 | Talzenna 1 mg hard capsules | Each hard capsule contains talazoparib tosylate equivalent to 1 mg talazoparib. For the full list of excipients, see section 6.1. | Hard capsule (capsule). Opaque, approximately 14 mm × 5 mm hard capsule with a light red cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 1” in black). | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | PLGB 00057/1673 | April 16, 2024 | June 25, 2025 | See Details |
| 307 | Talzenna 0.25 mg hard capsules | Each hard capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib. For the full list of excipients, see section 6.1. | Hard capsule (capsule). Opaque, approximately 14 mm x 5 mm hard capsule with an ivory cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.25” in black). | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | PLGB 00057/1672 | April 16, 2024 | June 25, 2025 | See Details |
| 306 | TOVIAZ 8 mg prolonged-release tablets | Each prolonged-release tablet contains fesoterodine fumarate 8 mg corresponding to 6.2 mg of fesoterodine. Excipients with known effect Each 8 mg prolonged-release tablet contains 0.525 mg of soya lecithin and 58.125 mg of lactose. For the full list of excipients, see section 6.1. | Prolonged-release tablet. The 8 mg tablets are blue, oval, biconvex, film-coated, and engraved on one side with the letters ‘FT’. | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | PLGB 00057/1647 | Jan. 1, 2021 | March 13, 2024 | See Details |
| 305 | TOVIAZ 4 mg prolonged-release tablets | Each prolonged-release tablet contains fesoterodine fumarate 4 mg corresponding to 3.1 mg of fesoterodine. Excipients with known effect Each 4 mg prolonged-release tablet contains 0.525 mg of soya lecithin and 91.125 mg of lactose. For the full list of excipients, see section 6.1. | Prolonged-release tablet. The 4 mg tablets are light blue, oval, biconvex, film-coated, and engraved on one side with the letters ‘FS’. | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | PLGB 00057/1646 | Jan. 1, 2021 | March 13, 2024 | See Details |
| 304 | Fuzeon 90 mg/ml powder and solvent for solution for injection | Each vial contains 108 mg enfuvirtide. Each ml of reconstituted solution contains 90 mg enfuvirtide. Excipient with known effect: sodium. Contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. White to off-white lyophilised powder. | Roche Products Limited 6 Falcon Way, Shire Park Welwyn Garden City AL7 1TW United Kingdom | PLGB 00031/0855 | Jan. 1, 2021 | Feb. 28, 2023 | See Details |
| 303 | BIMERVAX XBB.1.16 emulsion for injection COVID-19 Vaccine (recombinant, adjuvanted) | This is a single dose vial which contains 1 dose of 0.5 mL. One dose (0.5 mL) contains 40 micrograms of damlecovatein adjuvanted with SQBA. Damlecovatein is a SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion homodimer (Omicron XBB.1.16 - XBB.1.16 strain) produced by recombinant DNA technology using a plasmid expression vector in a CHO cell line. SQBA adjuvant containing per 0.5 mL dose: squalene (9.75 mg), polysorbate 80 (1.18 mg), sorbitan trioleate (1.18 mg), sodium citrate (0.66 mg), citric acid (0.04 mg) and water for injections. For the full list of excipients, see section 6.1. | Emulsion for injection (injection) White homogeneous emulsion. | Hipra Human Health, S.L.U. Avda. la Selva, 135 17170 Amer (Girona) SPAIN | PLGB 56346/0004 | Dec. 17, 2025 | See Details | |
| 302 | HEPLISAV B 20 micrograms solution for injection in pre-filled syringe Hepatitis B vaccine (recombinant DNA, adjuvanted) | One dose (0.5 mL) contains: Hepatitis B surface antigen (HBsAg)1,2 20 micrograms 1Adjuvanted with 3000 micrograms cytidine phosphoguanosine (CpG) 1018 adjuvant, a 22-mer phosphothioate oligonucleotide (PS-ODN) comprising microbial DNA-like unmethylated CpG motifs 2Produced in yeast cells (Hansenula polymorpha) by recombinant DNA technology For the full list of excipients, see section 6.1. | Solution for injection in pre-filled syringe. Clear to slightly opalescent, colourless to slightly yellow solution. | Dynavax GmbH Eichsfelder Strasse 11 D-40595 Düsseldorf Germany | PLGB 55725/0001 | Oct. 8, 2024 | See Details | |
| 301 | TAKHZYRO 150 mg solution for injection in pre-filled syringe | One unit (pre-filled syringe) contains 150 mg of lanadelumab* in 1 mL solution. *Lanadelumab is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection The solution is colourless to slightly yellow, appearing either clear or slightly opalescent. The solution has a pH of approximately 6.0 and an osmolality of approximately 300 mOsm/kg. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50-58 Baggot Street Lower Dublin 2 D02 HW68 Ireland Tel: +44(0) 3333 000181 E-mail: medinfoemea@takeda.com | PLGB 54937/0027 | April 8, 2024 | July 14, 2025 | See Details |
| 300 | Plenadren 20 mg modified-release tablets | Plenadren 20 mg modified-release tablets Each modified-release tablet contains hydrocortisone 20 mg. For the full list of excipients, see section 6.1. | Modified-release tablet. Plenadren 20 mg modified-release tablets The tablets are round (diameter 8 mm), convex and white. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50-58 Baggot Street Lower Dublin 2 D02 HW68 Ireland Tel: +44 (0)3333 000181 medinfoEMEA@takeda.com | PLGB 54937/0024 | Jan. 1, 2021 | May 14, 2025 | See Details |
| 299 | Plenadren 5 mg modified-release tablets | Plenadren 5 mg modified-release tablets Each modified-release tablet contains hydrocortisone 5 mg | Modified-release tablet. Plenadren 5 mg modified-release tablets The tablets are round (diameter 8 mm), convex and pink. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50-58 Baggot Street Lower Dublin 2 D02 HW68 Ireland Tel: +44 (0)3333 000181 medinfoEMEA@takeda.com | PLGB 54937/0023 | Jan. 1, 2021 | May 14, 2025 | See Details |
| 298 | Replagal 1 mg/ml concentrate for solution for infusion. | 1 ml of concentrate for solution for infusion contains 1 mg of agalsidase alfa*. Each vial of 3.5 ml of concentrate contains 3.5 mg of agalsidase alfa. *agalsidase alfa is the human protein a-galactosidase A produced in a human cell line by genetic engineering technology. Excipients with known effect This medicinal product contains 14.2 mg sodium per vial. This medicinal product contains 0.836 mg of polysorbate 20 per vial. For the full list of excipients, see section 6.1. | Concentrate for solution for infusion. A clear and colourless solution. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 – 58 Baggot Street Lower 13 Dublin 2 D02 HW68 Ireland | PLGB 54937/0022 | Jan. 1, 2021 | Jan. 20, 2026 | See Details |
| 297 | Elaprase 2 mg/ml concentrate for solution for infusion | Each vial contains 6 mg of idursulfase. Each ml contains 2 mg of idursulfase*. Excipient with known effect Each vial contains 0.482 mmol of sodium. For the full list of excipients, see section 6.1. * idursulfase is produced by recombinant DNA technology in a continuous human cell line. | Concentrate for solution for infusion (sterile concentrate). A clear to slightly opalescent, colourless solution. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 D02 HW68 Ireland | PLGB 54937/0021 | Jan. 1, 2021 | April 24, 2025 | See Details |
| 296 | TAKHZYRO 300 mg solution for injection in pre-filled syringe | One pre-filled syringe contains 300 mg of lanadelumab* in 2 mL solution. *Lanadelumab is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection The solution is colourless to slightly yellow, appearing either clear or slightly opalescent. The solution has a pH of approximately 6.0 and an osmolality of approximately 300 mOsm/kg. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 D02 HW68 Ireland | PLGB 54937/0020 | Nov. 7, 2023 | July 14, 2025 | See Details |
| 295 | Xagrid 0.5 mg hard capsules. | Each hard capsule contains 0.5 mg anagrelide (as anagrelide hydrochloride). Excipient(s) with known effect Each hard capsule contains lactose monohydrate (53.7 mg) and anhydrous lactose (65.8 mg). For the full list of excipients, see section 6.1. | Hard capsule. An opaque white hard capsule imprinted with S 063. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 Ireland | PLGB 54937/0019 | Jan. 1, 2021 | April 20, 2023 | See Details |
| 294 | VPRIV 400 Units powder for solution for infusion | Each vial contains 400 Units* of velaglucerase alfa**. After reconstitution, one ml of the solution contains 100 Units of velaglucerase alfa. *An enzyme unit is defined as the amount of enzyme that is required to convert one micromole of p-nitrophenyl ß-D-glucopyranoside to p-nitrophenol per minute at 37 ºC. **produced in an HT-1080 human fibroblast cell line by recombinant DNA technology. Excipient with known effect Each vial contains 12.15 mg sodium. For the full list of excipients, see section 6.1. | Powder for solution for infusion. White to off-white powder. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 D02 HW68 Ireland | PLGB 54937/0018 | Jan. 1, 2021 | Dec. 18, 2024 | See Details |
| 293 | TAKHZYRO 300 mg solution for injection | One unit vial contains 300 mg of lanadelumab* in 2 mL solution. *Lanadelumab is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection The solution is colourless to slightly yellow, appearing either clear or slightly opalescent. The solution has a pH of approximately 6.0 and an osmolality of approximately 300 mOsm/kg. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 D02 HW68 Ireland | PLGB 54937/0017 | Nov. 7, 2023 | July 14, 2025 | See Details |
| 292 | Revestive 5 mg powder and solvent for solution for injection | One vial of powder contains 5 mg of teduglutide*. After reconstitution, each vial contains 5 mg teduglutide in 0.5 ml of solution, corresponding to a concentration of 10 mg/ml. *A glucagon-like peptide-2 (GLP-2) analogue produced in Escherichia coli cells by recombinant DNA technology. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. The powder is white and the solvent is clear and colourless. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 Ireland | PLGB 54937/0016 | Jan. 1, 2021 | Dec. 20, 2024 | See Details |
| 291 | Revestive 1.25 mg powder and solvent for solution for injection | One vial of powder contains 1.25 mg of teduglutide*. After reconstitution, each vial contains 1.25 mg teduglutide in 0.5 ml of solution, corresponding to a concentration of 2.5 mg/ml. *A glucagon-like peptide-2 (GLP-2) analogue produced in Escherichia coli cells by recombinant DNA technology. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. The powder is white and the solvent is clear and colourless. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 Ireland | PLGB 54937/0015 | Jan. 1, 2021 | Dec. 20, 2024 | See Details |
| 290 | Resolor 2 mg film-coated tablets. | Each film-coated tablet contains 2 mg prucalopride (as succinate). Excipients with known effect: Each film-coated tablet contains 156.75 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Pink, round, biconvex tablets marked “PRU 2” on one side. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 Ireland | PLGB 54937/0014 | Jan. 1, 2021 | March 9, 2023 | See Details |
| 289 | Resolor 1 mg film-coated tablets. | Each film-coated tablet contains 1 mg prucalopride (as succinate). Excipients with known effect: Each film-coated tablet contains 142.5 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). White to off-white, round, biconvex tablets marked “PRU 1” on one side. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 Ireland | PLGB 54937/0013 | Jan. 1, 2021 | March 9, 2023 | See Details |
| 288 | Natpar 75 micrograms/dose powder and solvent for solution for injection | Natpar 75 micrograms Each dose contains 75 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution. Each cartridge contains 1050 micrograms parathyroid hormone (rDNA). *Parathyroid hormone (rDNA), produced in E. coli using recombinant DNA technology, is identical to the 84 amino acid sequence of endogenous human parathyroid hormone. Excipient(s) with known effect Each dose contains 0.32 mg of sodium. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. The powder is white and the solvent is a clear, colourless solution. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 D02 HW68 Ireland | PLGB 54937/0012 | Jan. 6, 2026 | Jan. 6, 2026 | See Details |
| 287 | Natpar 50 micrograms/dose powder and solvent for solution for injection | Natpar 50 micrograms Each dose contains 50 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution. Each cartridge contains 700 micrograms parathyroid hormone (rDNA). *Parathyroid hormone (rDNA), produced in E. coli using recombinant DNA technology, is identical to the 84 amino acid sequence of endogenous human parathyroid hormone. Excipient(s) with known effect Each dose contains 0.32 mg of sodium. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. The powder is white and the solvent is a clear, colourless solution. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 D02 HW68 Ireland | PLGB 54937/0011 | Jan. 6, 2026 | Jan. 6, 2026 | See Details |
| 286 | Natpar 25 micrograms/dose powder and solvent for solution for injection | Natpar 25 micrograms Each dose contains 25 micrograms parathyroid hormone (rDNA)* in 71.4 microlitre solution following reconstitution. Each cartridge contains 350 micrograms parathyroid hormone (rDNA). *Parathyroid hormone (rDNA), produced in E. coli using recombinant DNA technology, is identical to the 84 amino acid sequence of endogenous human parathyroid hormone. Excipient(s) with known effect Each dose contains 0.32 mg of sodium. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. The powder is white and the solvent is a clear, colourless solution. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 D02 HW68 Ireland | PLGB 54937/0010 | Jan. 6, 2026 | Jan. 6, 2026 | See Details |
| 285 | Natpar 100 micrograms/dose powder and solvent for solution for injection | Natpar 100 micrograms Each dose contains 100 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution. Each cartridge contains 1400 micrograms parathyroid hormone (rDNA). *Parathyroid hormone (rDNA), produced in E. coli using recombinant DNA technology, is identical to the 84 amino acid sequence of endogenous human parathyroid hormone. Excipient(s) with known effect Each dose contains 0.32 mg of sodium. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. The powder is white and the solvent is a clear, colourless solution. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 D02 HW68 Ireland | PLGB 54937/0009 | Jan. 6, 2026 | Jan. 6, 2026 | See Details |
| 284 | Intuniv 4 mg prolonged-release tablets | Intuniv 4 mg prolonged-release tablet Each tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine. Excipient(s) with known effect Each 4 mg tablet contains 50.42 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. | Prolonged-release tablet Intuniv 4 mg prolonged-release tablet 12.34mm x 6.10mm oblong shaped, green tablets debossed with ‘4MG’ on one side and ‘503’ on the other side. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland. medinfoEMEA@takeda.com | PL 54937/0008 | Jan. 1, 2021 | May 15, 2023 | See Details |
| 283 | Intuniv 3 mg prolonged-release tablets | Intuniv 3 mg prolonged-release tablet Each tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine. Excipient(s) with known effect Each tablet contains 37.81 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. | Prolonged-release tablet Intuniv 3 mg prolonged-release tablet 7.94mm round, green tablets debossed with ‘3MG’ on one side and ‘503’ on the other side | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland. medinfoEMEA@takeda.com | PL 54937/0007 | Jan. 1, 2021 | May 15, 2023 | See Details |
| 282 | Intuniv 2 mg prolonged-release tablets | Intuniv 2 mg prolonged-release tablet Each tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine. Excipient(s) with known effect Each tablet contains 44.82 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. | Prolonged-release tablet Intuniv 2 mg prolonged-release tablet 12.34mm x 6.10mm oblong shaped, white to off-white tablets debossed with ‘2MG’ on one side and “503” on the other side. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland. medinfoEMEA@takeda.com | PL 54937/0006 | Jan. 1, 2021 | May 15, 2023 | See Details |
| 281 | Intuniv 1 mg prolonged-release tablets | Intuniv 1 mg prolonged-release tablet Each tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine. Excipient(s) with known effect Each tablet contains 22.41 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. | Prolonged-release tablet Intuniv 1 mg prolonged-release tablet 7.14mm round, white to off-white tablets debossed with ‘1MG’ on one side and ‘503’ on the other side. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland. medinfoEMEA@takeda.com | PL 54937/0005 | Jan. 1, 2021 | May 15, 2023 | See Details |
| 280 | Firazyr 30 mg solution for injection in pre-filled syringe | Each pre-filled syringe of 3 ml contains icatibant acetate equivalent to 30 mg icatibant. Each ml of the solution contains 10 mg of icatibant. Excipient(s) with known effect For the full list of excipients, see section 6.1. | Solution for injection. The solution is a clear and colourless liquid. | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 D02 HW68 Ireland | PLGB 54937/0004 | Dec. 5, 2025 | See Details | |
| 279 | Nuvaxovid JN.1 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) | These are single dose vials. One single dose vial contains 1 dose of 0.5 mL, see section 6.5. One dose (0.5 mL) contains 5 micrograms of the SARS-CoV-2 (Omicron JN.1) spike protein* and is adjuvanted with Matrix-M. Adjuvant Matrix-M containing per 0.5 mL dose: Fraction-A (42.5 micrograms) and Fraction-C (7.5 micrograms) of Quillaja saponaria Molina extract. *produced by recombinant DNA technology using a baculovirus expression system in an insect cell line that is derived from Sf9 cells of the Spodoptera frugiperda species. For the full list of excipients, see section 6.1. | Dispersion for injection (injection). The dispersion is colourless to slightly yellow, clear to mildly opalescent (pH 7.2). | Novavax CZ a.s. Líbalova 2348/1, Chodov 149 00 Praha 4 Czechia | PLGB 54180/0004 | Nov. 13, 2024 | Nov. 13, 2024 | See Details |
| 278 | Zevalin 1.6 mg/ml kit for radiopharmaceutical preparations for infusion | Zevalin is supplied as a kit for the preparation of yttrium-90 radiolabelled ibritumomab tiuxetan. The kit contains one ibritumomab tiuxetan vial, one sodium acetate vial, one formulation buffer vial, and one empty reaction vial. The radionuclide is not part of the kit. One ibritumomab tiuxetan vial contains 3.2 mg ibritumomab tiuxetan* in 2 ml solution (1.6 mg per ml). *murine IgG1 monoclonal antibody produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line and conjugated to the chelating agent MX- DTPA. The final formulation after radiolabelling contains 2.08 mg ibritumomab tiuxetan [90Y] in a total volume of 10 ml. Excipients This medicinal product can contain up to 28 mg sodium per dose, depending on the radioactivity concentration. To be taken into consideration by patients on a controlled sodium diet. For the full list of excipients, see section 6.1. | Kit for radiopharmaceutical preparations for infusion. Ibritumomab tiuxetan vial: Clear colourless solution. Sodium acetate vial: Clear colourless solution. Formulation buffer vial: Clear yellow to amber coloured solution. | Ceft Biopharma s.r.o. Trtinova 260/1 Cakovice, 196 00 Praha 9 Czech Republic | PLGB 53745/0001 | Jan. 1, 2021 | See Details | |
| 277 | Vaxneuvance® suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed) | 1 dose (0.5 mL) contains: Pneumococcal polysaccharide serotype 11,2 2.0 micrograms Pneumococcal polysaccharide serotype 31,2 2.0 micrograms Pneumococcal polysaccharide serotype 41,2 2.0 micrograms Pneumococcal polysaccharide serotype 51,2 2.0 micrograms Pneumococcal polysaccharide serotype 6A1,2 2.0 micrograms Pneumococcal polysaccharide serotype 6B1,2 4.0 micrograms Pneumococcal polysaccharide serotype 7F1,2 2.0 micrograms Pneumococcal polysaccharide serotype 9V1,2 2.0 micrograms Pneumococcal polysaccharide serotype 141,2 2.0 micrograms Pneumococcal polysaccharide serotype 18C1,2 2.0 micrograms Pneumococcal polysaccharide serotype 19A1,2 2.0 micrograms Pneumococcal polysaccharide serotype 19F1,2 2.0 micrograms Pneumococcal polysaccharide serotype 22F1,2 2.0 micrograms Pneumococcal polysaccharide serotype 23F1,2 2.0 micrograms Pneumococcal polysaccharide serotype 33F1,2 2.0 micrograms 1Conjugated to CRM197 carrier protein. CRM197 is a nontoxic mutant of diphtheria toxin (originating from Corynebacterium diphtheriae C7) expressed recombinantly in Pseudomonas fluorescens. 2Adsorbed on aluminium phosphate adjuvant. 1 dose (0.5 mL) contains 125 micrograms aluminium (Al3+) and approximately 30 micrograms CRM197 carrier protein. For the full list of excipients, see section 6.1. | Suspension for injection (injection). The vaccine is an opalescent suspension. | Merck Sharp & Dohme (UK) Limited 120 Moorgate London EC2M 6UR United Kingdom | PLGB 53095/0090 | Dec. 16, 2021 | Dec. 14, 2023 | See Details |
| 276 | ProQuad® powder and solvent for suspension for injection ProQuad® powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live). | After reconstitution, one dose (0.5 mL) contains: Measles virus1 Enders’ Edmonston strain (live, attenuated) not less than 3.00 log10 TCID50* Mumps virus1 Jeryl Lynn™ (Level B) strain (live, attenuated) not less than 4.30 log10 TCID50* Rubella virus2 Wistar RA 27/3 strain (live, attenuated) not less than 3.00 log10 TCID50* Varicella virus3 Oka/Merck strain (live, attenuated) not less than 3.99 log10 PFU** *50% tissue culture infectious dose **plaque-forming units (1) Produced in chick embryo cells. (2) Produced in human diploid lung (WI-38) fibroblasts. (3) Produced in human diploid (MRC-5) cells. The vaccine may contain traces of recombinant human albumin (rHA). This vaccine contains a trace amount of neomycin. See section 4.3. Excipient(s) with known effect The vaccine contains 16 milligrams of sorbitol per dose. See section 4.4. For the full list of excipients, see section 6.1. | Powder and solvent for suspension for injection Before reconstitution, the powder is a white to pale yellow compact crystalline cake and the solvent is a clear colourless liquid. | Merck Sharp & Dohme (UK) Limited 120 Moorgate London EC2M 6UR United Kingdom | PLGB 53095/0050 | Jan. 1, 2021 | Dec. 17, 2025 | See Details |
| 275 | M-M-RvaxPro® powder and solvent for suspension for injection M-M-RvaxPro® powder and solvent for suspension for injection in pre-filled syringe Measles, mumps and rubella vaccine (live) | After reconstitution, one dose (0.5 mL) contains: Measles virus1 Enders’ Edmonston strain (live, attenuated) ………..….not less than 1x103 TCID50* Mumps virus1 Jeryl Lynn™ [Level B] strain (live, attenuated)……...…not less than 12.5x103 TCID50* Rubella virus2 Wistar RA 27/3 strain (live, attenuated) …………….….not less than 1x103 TCID50* *50% tissue culture infectious dose 1 produced in chick embryo cells. 2 produced in WI-38 human diploid lung fibroblasts. The vaccine may contain traces of recombinant human albumin (rHA). This vaccine contains a trace amount of neomycin. See section 4.3. Excipient(s) with known effect The vaccine contains 14.5 milligrams of sorbitol per dose. See section 4.4. For the full list of excipients, see section 6.1. | Powder and solvent for suspension for injection (powder for injection). Before reconstitution, the powder is a light yellow compact crystalline cake and the solvent is a clear colourless liquid. | Merck Sharp & Dohme (UK) Limited 120 Moorgate London EC2M 6UR UK | PLGB 53095/0041 | Jan. 1, 2021 | Dec. 17, 2025 | See Details |
| 274 | HBVAXPRO 5 micrograms suspension for injection HBVAXPRO 5 micrograms suspension for injection in pre-filled syringe Hepatitis B vaccine (recombinant DNA) | One dose (0.5 mL) contains: Hepatitis B virus surface antigen, recombinant (HBsAg) *................... 5 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+) * produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology. This vaccine may contain traces of formaldehyde and potassium thiocyanate, which are used during the manufacturing process. See sections 4.3, 4.4 and 4.8. Excipient(s) with known effect: Sodium less than 1 mmol (23 mg) per dose. For the full list of excipients, see section 6.1. | Suspension for injection Slightly opaque white suspension. | Merck Sharp & Dohme (UK) Limited 120 Moorgate London EC2M 6UR United Kingdom | PLGB 53095/0027 | Jan. 1, 2021 | Dec. 15, 2022 | See Details |
| 273 | HBVAXPRO® 40 micrograms suspension for injection Hepatitis B vaccine (recombinant DNA) | One dose (1 mL) contains: Hepatitis B virus surface antigen, recombinant (HBsAg) *....................40 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+) * produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology. This vaccine may contain traces of formaldehyde and potassium thiocyanate which are used during the manufacturing process. See sections 4.3, 4.4 and 4.8. Excipient(s) with known effect: Sodium less than 1mmol (23 mg) per dose. For the full list of excipients, see section 6.1. | Suspension for injection Slightly opaque white suspension. | Merck Sharp & Dohme (UK) Limited 120 Moorgate London EC2M 6UR United Kingdom | PLGB 53095/0026 | Jan. 1, 2021 | Dec. 15, 2022 | See Details |
| 272 | HBVAXPRO® 10 micrograms suspension for injection HBVAXPRO® 10 micrograms suspension for injection in pre-filled syringe Hepatitis B vaccine (recombinant DNA) | One dose (1 mL) contains: Hepatitis B virus surface antigen, recombinant (HBsAg) *................... 10 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+) * produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology. This vaccine may contain traces of formaldehyde and potassium thiocyanate which are used during the manufacturing process. See sections 4.3, 4.4 and 4.8. Excipient(s) with known effect: Sodium less than 1mmol (23 mg) per dose. For the full list of excipients, see section 6.1. | Suspension for injection Slightly opaque white suspension. | Merck Sharp & Dohme (UK) Limited 120 Moorgate London EC2M 6UR United Kingdom | PLGB 53095/0025 | Jan. 1, 2021 | Dec. 15, 2022 | See Details |
| 271 | Gardasil® 9 suspension for injection. Gardasil® 9 suspension for injection in a pre-filled syringe. Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed) | 1 dose (0.5 ml) contains approximately: Human Papillomavirus1 Type 6 L1 protein2,3 30 micrograms Human Papillomavirus1 Type 11 L1 protein2,3 40 micrograms Human Papillomavirus1 Type 16 L1 protein2,3 60 micrograms Human Papillomavirus1 Type 18 L1 protein2,3 40 micrograms Human Papillomavirus1 Type 31 L1 protein2,3 20 micrograms Human Papillomavirus1 Type 33 L1 protein2,3 20 micrograms Human Papillomavirus1 Type 45 L1 protein2,3 20 micrograms Human Papillomavirus1 Type 52 L1 protein2,3 20 micrograms Human Papillomavirus1 Type 58 L1 protein2,3 20 micrograms 1Human Papillomavirus = HPV. 2L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology. 3Adsorbed on amorphous aluminium hydroxyphosphate sulfate adjuvant (0.5 milligrams Al). For the full list of excipients, see section 6.1. | Suspension for injection. Clear liquid with white precipitate. | Merck Sharp & Dohme (UK) Limited 120 Moorgate London EC2M 6UR United Kingdom | PLGB 53095/0023 | Jan. 1, 2021 | Sept. 13, 2024 | See Details |
| 270 | Vaxelis suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated), and Haemophilus type b conjugate vaccine (adsorbed). | One dose (0.5 mL) contains: Diphtheria Toxoid1 not less than 20 IU6 Tetanus Toxoid1 not less than 40 IU6 Bordetella pertussis antigens1 Pertussis Toxoid (PT) 20 micrograms Filamentous Haemagglutinin (FHA) 20 micrograms Pertactin (PRN) 3 micrograms Fimbriae Types 2 and 3 (FIM) 5 micrograms Hepatitis B surface antigen2,3 10 micrograms Poliovirus (Inactivated)4 Type 1 (Mahoney) 29 D antigen units5 Type 2 (MEF-1) 7 D antigen units5 Type 3 (Saukett) 26 D antigen units5 Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) 3 micrograms Conjugated to meningococcal protein2 50 micrograms 1 adsorbed on aluminium phosphate (0.17 mg Al3+) 2 adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.15 mg Al3+) 3 produced in yeast (Saccharomyces cerevisiae) cells by recombinant DNA technology 4 produced in Vero cells 5 These antigen quantities are strictly the same as those previously expressed as 40-8-32 D-antigen units, for virus type 1, 2 and 3 respectively, when measured by another suitable immunochemical method 6 or equivalent activity determined by an immunogenicity evaluation. The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin, polymyxin B, and bovine serum albumin which are used during the manufacturing process (see section 4.3). For the full list of excipients, see section 6.1. | Suspension for injection (injection). Uniform, cloudy, white to off-white suspension. | MCM Vaccine B.V. Robert Boyleweg 4 2333 CG Leiden The Netherlands | PLGB 50692/0001 | Oct. 15, 2025 | See Details | |
| 269 | Rivaroxaban 2.5 mg film-coated tablets | Each film-coated tablet contains 2.5 mg rivaroxaban. Excipient with known effect Each film-coated tablet contains 26.46 mg lactose (as monohydrate), see section 4.4. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet) Round, biconvex, yellow film-coated tablets (6 mm diameter) engraved with "2.5" on one side and plain on the other side. | Biocon Pharma UK Limited 16 Great Queen Street, Covent Garden London, WC2B 5AH, United Kingdom | PLGB 50674/0025 | Sept. 27, 2023 | Sept. 27, 2023 | See Details |
| 268 | Eladynos 80 micrograms/dose solution for injection in pre-filled pen. | Each dose (40 microliters) contains 80 micrograms of abaloparatide. Each pre-filled pen contains 3 mg of abaloparatide in 1.5 mL of solution (corresponding to 2 milligrams per mL). For the full list of excipients, see section 6.1. | Solution for injection (injection). Colourless, clear solution. | Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1 D01 YE64 Ireland | PLGB 49876/0025 | March 27, 2023 | Jan. 22, 2024 | See Details |
| 267 | Cell-based Trivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe. Influenza vaccine, prepared in cell cultures | Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*: A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/Georgia/12/2022, CVR-167) 15 micrograms HA** A/District of Columbia/27/2023 (H3N2)-like strain (A/Victoria/800/2024, CVR-289) 15 micrograms HA** B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) 15 micrograms HA** per 0.5 ml dose ………………………………………. * propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin The vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2025/2026 season. Cell-based Trivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe may contain traces of beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80. For the full list of excipients, see section 6.1. | Suspension for injection in pre-filled syringe (injection). Clear to slightly opalescent liquid. | Seqirus UK Ltd. Point, 29 Market Street, Maidenhead SL6 8AA, UK | PLGB 47991/0015 | July 1, 2024 | Dec. 11, 2025 | See Details |
| 266 | Adjuvanted Trivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1 | Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*: Per 0.5 ml dose A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238) 15 micrograms HA** A/Croatia/10136RV/2023 (H3N2)-like strain (A/Croatia/10136RV/2023, X-425A) 15 micrograms HA** B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26) 15 micrograms HA** *propagated in fertilised hens’ eggs from healthy chicken flocks and adjuvanted with MF59C.1 **haemagglutinin Adjuvant MF59C.1 containing per 0.5 ml dose: squalene (9.75 mg), polysorbate 80 (1.175 mg), sorbitan trioleate (1.175 mg), sodium citrate (0.66 mg) and citric acid (0.04 mg). This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU recommendation for the 2025/2026 season. Adjuvanted Trivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe may contain traces of eggs such as ovalbumin or chicken proteins, kanamycin and neomycin sulphate, formaldehyde, hydrocortisone, cetyltrimethylammonium bromide (CTAB) which are used during the manufacturing process (see section 4.3). For the full list of excipients, see section 6.1. | Suspension for injection in pre-filled syringe (injection). Milky-white suspension. | Seqirus UK Ltd. Point, 29 Market Street, Maidenhead SL6 8AA, United Kingdom | PLGB 47991/0014 | July 2, 2024 | June 27, 2025 | See Details |
| 265 | Adjuvanted Zoonotic Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre filled syringe Zoonotic influenza vaccine (H5N8) (surface antigen, inactivated, adjuvanted). | Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Astrakhan/3212/2020 (H5N8)-like strain (CBER-RG8A) (clade 2.3.4.4b) 7.5 micrograms** per 0.5 ml dose * propagated in fertilised hens’ eggs from healthy chicken flocks ** expressed in micrograms haemagglutinin. Adjuvant MF59C.1 containing: squalene 9.75 milligrams per 0.5 ml polysorbate 80 1.175 milligrams per 0.5 ml sorbitan trioleate 1.175 milligrams per 0.5 ml Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 may contain trace residues of egg and chicken proteins, ovalbumin, kanamycin, neomycin sulphate, formaldehyde, hydrocortisone and cetyltrimethylammonium bromide which are used during the manufacturing process (see section 4.3). For the full list of excipients see section 6.1. | Suspension for injection (injection). Milky-white liquid. | Seqirus UK Ltd Point, 29 Market Street Maidenhead SL6 8AA UK | PLGB 47991/0013 | Oct. 6, 2023 | Nov. 12, 2024 | See Details |
| 264 | Cell-based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe. Influenza vaccine, prepared in cell cultures | Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*: A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/Georgia/12/2022 CVR-167) 15 micrograms HA** A/Massachusetts/18/2022 (H3N2)-like strain (A/Sydney/1304/2022, wild type) 15 micrograms HA** B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) 15 micrograms HA** B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type) 15 micrograms HA** per 0.5 ml dose ………………………………………. * propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin The vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2024/2025 season. Cell-based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe may contain traces of beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80. For the full list of excipients, see section 6.1. | Suspension for injection in pre-filled syringe (injection). Clear to slightly opalescent liquid. | Seqirus UK Ltd. The Point, 29 Market Street, Maidenhead SL6 8AA, UK | PLGB 47991/0006 | Dec. 17, 2025 | Dec. 17, 2025 | See Details |
| 263 | Verorab, powder and solvent for suspension for injection Rabies vaccine, inactivated | After reconstitution with 0.5 mL solvent, 1 vial contains: Rabies virusa, WISTAR Rabies PM/WI38 1503-3M strain (inactivated)........................3.25 IUb a Produced in Vero cells b Quantity measured according to the ELISA test against the international standard Excipient with known effect: Phenylalanine ..........................................................................................4.1 micrograms For the full list of excipients, see section 6.1. Verorab may contain traces of polymyxin B, streptomycin and neomycin, used in the manufacturing process (see section 4.3). | Powder and solvent for suspension for injection. Before reconstitution, the powder is uniform white in colour. The solvent is a clear, colourless solution. | Sanofi Pasteur 14 Espace Henry Vallée 69007 Lyon France Distributed in the UK by: Sanofi 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK | PLGB 46602/0029 | Nov. 1, 2023 | May 10, 2024 | See Details |
| 262 | Influvac sub-unit TIV suspension for injection in pre-filled syringe Influenza vaccine TIV Viatris suspension for injection in pre-filled syringe (influenza vaccine, surface antigen, inactivated). | Influenza virus surface antigens (inactivated) (haemagglutinin and neuraminidase) of the following strains*: - A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238) 15 micrograms HA ** - A/Croatia/10136RV/2023 (H3N2)-like strain (A/Croatia/10136RV/2023, X-425A) 15 micrograms HA ** - B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26) 15 micrograms HA ** per 0.5 ml dose * propagated in fertilised hens’ eggs from healthy chicken flocks ** haemagglutinin. This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2025/2026 season. For a full list of excipients see section 6.1. Influenza vaccine TIV Viatris may contain traces of eggs (such as ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin, which are used during the manufacturing process (see section 4.3). | Suspension for injection in prefilled syringe. A colourless clear liquid. | Viatris Products Limited, Station Close, Potters Bar, EN6 1TL, United Kingdom. | PLGB 46302/0251 | Dec. 5, 2024 | Jan. 8, 2026 | See Details |
| 261 | Nexium Control 20 mg gastro-resistant tablets | Each gastro-resistant tablet contains 20 mg esomeprazole (as magnesium trihydrate) Excipient(s) with known effect Each gastro-resistant tablet contains 28 mg sucrose. For the full list of excipients, see section 6.1. | Gastro-resistant tablet. A light pink, oblong, biconvex, film-coated, gastro-resistant tablet of 14 mm x 7 mm engraved with ‘20 mG’ on one side and ‘A/EH’ on the other side. | Haleon UK Trading Limited, The Heights, Weybridge, Surrey, KT13 0NY, U.K. | PLGB 44673/0225 | Jan. 18, 2023 | Jan. 6, 2026 | See Details |
| 260 | Mifamurtide 4 mg powder for concentrate for dispersion for infusion | Each vial contains 4 mg mifamurtide*. After reconstitution, each mL of suspension in the vial contains 0.08 mg mifamurtide. *fully synthetic analogue of a component of Mycobacterium sp. cell wall. For the full list of excipients, see section 6.1. | Powder for concentrate for dispersion for infusion White to off-white homogeneous cake or powder. | Takeda France SAS Immeuble Pacific 11-13 Cours Valmy 92800 - Puteaux France | PLGB 44272/0002 | Jan. 1, 2021 | July 26, 2024 | See Details |
| 259 | IXCHIQ powder and solvent for solution for injection Chikungunya vaccine (live) | After reconstitution, one dose (0.5 ml) contains: Chikungunya virus (CHIKV) ?5nsP3 strain (live, attenuated)* not less than 3.0 log10 TCID50** * Produced in Vero cells ** 50% tissue culture infectious dose This product contains genetically modified organisms (GMOs) For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. Before reconstitution, the lyophilized vaccine is a white to slightly yellowish homogeneous powder. The solvent is a clear colourless liquid. | Valneva Austria GmbH Campus Vienna Biocenter 3 1030 Vienna, Austria | PLGB 43185/0007 | Feb. 4, 2025 | Feb. 4, 2025 | See Details |
| 258 | Zaluron XL 150 mg prolonged-release tablets Quetiapine Northumbria 150 mg prolonged-release tablets | This medicine 150 mg contains 150 mg quetiapine (as quetiapine fumarate) Excipient with known effect: 42 mg lactose per tablet For the full list of excipients, see section 6.1. | Prolonged-release tablet A white to off white, oblong biconvex tablet, 13.6 mm in length, 6.6 mm in width and 4.2 mm in thickness, engraved with “150” on one side. | Fontus Health Ltd 60 Lichfield Street Walsall WS4 2BX United Kingdom | PLGB 42924/0025 | Dec. 9, 2014 | Sept. 5, 2025 | See Details |
| 257 | Thiotepa Riemser 100 mg powder for concentrate for solution for infusion | One vial of powder contains 100 mg thiotepa. After reconstitution with 10 mL of water for injections, each mL of solution contains 10 mg thiotepa (10 mg/mL). For the full list of excipients, see section 6.1. | Powder for concentrate for solution for infusion (powder for concentrate). White crystalline powder. | Esteve Pharmaceuticals GmbH Hohenzollerndamm 150-151 14199 Berlin Germany | PLGB 42336/0009 | April 1, 2021 | May 9, 2023 | See Details |
| 256 | Thiotepa Riemser 15 mg powder for concentrate for solution for infusion | One vial of powder contains 15 mg thiotepa. After reconstitution with 1.5 mL of water for injections, each mL of solution contains 10 mg thiotepa (10 mg/mL). For the full list of excipients, see section 6.1. | Powder for concentrate for solution for infusion (powder for concentrate). White crystalline powder. | Esteve Pharmaceuticals GmbH Hohenzollerndamm 150-151 14199 Berlin Germany | PLGB 42336/0008 | April 1, 2021 | April 4, 2022 | See Details |
| 255 | Humira 40 mg solution for injection in pre-filled pen | Each 0.4 ml single dose pre-filled pen contains 40 mg of adalimumab. Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells. For the full list of excipients, see section 6.1. | Solution for injection. (injection) Clear, colourless solution. | AbbVie Ltd Maidenhead Berkshire SL6 4UB UK | PLGB 41042/0025 | Jan. 1, 2021 | Oct. 2, 2024 | See Details |
| 254 | Nordimet 12.5 mg solution for injection in pre-filled pen | One ml of solution contains 25 mg of methotrexate. Nordimet 12.5 mg solution for injection in pre-filled pen Each pre-filled pen contains 12.5 mg methotrexate in 0.5 mL. For the full list of excipients, see section 6.1. | Solution for injection (injection) Clear, yellow solution with a pH of 8.0-9.0 and an osmolality of approximately 300 mOsm/kg. | Nordic Group B.V. Siriusdreef 41 2132 WT Hoofddorp The Netherlands | PLGB 40621/0025 | June 21, 2021 | Dec. 9, 2025 | See Details |
| 253 | Vaxchora effervescent powder and powder for oral suspension Cholera vaccine (recombinant, live, oral) | Each dose of vaccine contains 4 x 108 to 2 x 109 viable cells of Vibrio cholerae live, attenuated strain CVD 103-HgR1. 1 Produced by recombinant DNA technology. This product contains genetically modified organisms (GMOs). Excipients with known effect Each dose of vaccine contains approximately 2.3 grams of lactose, 12.5 milligrams of sucrose, and 863 milligrams of sodium. For the full list of excipients see section 6.1. | Effervescent powder and powder for oral suspension. White-to-off-white buffer powder and white-to-beige active ingredient powder. | Bavarian Nordic A/S Philip Heymans Alle 3 DK-2900 Hellerup Denmark | PLGB 40365/0007 | Oct. 29, 2025 | See Details | |
| 252 | IMVANEX suspension for injection Smallpox and mpox vaccine (Live Modified Vaccinia Virus Ankara) | One dose (0.5 ml) contains: Modified Vaccinia Ankara – Bavarian Nordic Live virus1 no less than 5 x 107 Inf.U* *infectious units 1Produced in chick embryo cells This vaccine contains trace residues of chicken protein, benzonase, gentamicin and ciprofloxacin (see section 4.3). For the full list of excipients, see section 6.1. | Suspension for injection. Light yellow to pale white colored, clear to milky suspension. | Bavarian Nordic A/S Philip Heymans Alle 3 DK-2900 Hellerup Denmark | PLGB 40365/0002 | Jan. 1, 2021 | Dec. 12, 2025 | See Details |
| 251 | TEPADINA 200 mg powder and solvent for solution for infusion | One bag contains 200 mg thiotepa. After reconstitution with the solvent, each mL of solution contains 1 mg of thiotepa. Excipient with known effect When reconstituted, each bag contains 709 mg (30.8 mmol) of sodium. For the full list of excipients, see section 6.1. | Powder and solvent for solution for infusion. Powder: white powder. Solvent: clear solution, essentially free from visible particulates, pH 4.5-7.0. | ADIENNE S.r.l. S.U. Via Galileo Galilei, 19 20867 Caponago (MB) Italy Tel: +39-02 40700445 adienne@adienne.com | PLGB 40008/0010 | Jan. 15, 2026 | Jan. 15, 2026 | See Details |
| 250 | TEPADINA 400 mg powder and solvent for solution for infusion | One bag contains 400 mg thiotepa. After reconstitution with the solvent, each mL of solution contains 1 mg of thiotepa. Excipient with known effect When reconstituted, each bag contains 1 418 mg (61.6 mmol) of sodium. For the full list of excipients, see section 6.1. | Powder and solvent for solution for infusion. Powder: white powder. Solvent: clear solution, essentially free from visible particulates, pH 4.5-7.0. | ADIENNE S.r.l. S.U. Via Galileo Galilei, 19 20867 Caponago (MB) Italy Tel: +39-02 40700445 adienne@adienne.com | PLGB 40008/0004 | May 25, 2021 | Nov. 20, 2023 | See Details |
| 249 | TEPADINA 15 mg powder for concentrate for solution for infusion | - One vial of powder contains 15 mg thiotepa. - After reconstitution with 1.5 mL of water for injections, each mL of solution contains 10 mg thiotepa (10 mg/mL). - - For the full list of excipients, see section 6.1. | Powder for concentrate for solution for infusion. White crystalline powder. | ADIENNE S.r.l. S.U. Via Galileo Galilei, 19 - 20867 Caponago (MB) Italy - Tel: +39-02 40700445 - adienne@adienne.com | PLGB 40008/0003 | Jan. 1, 2021 | Feb. 11, 2025 | See Details |
| 248 | TEPADINA 100 mg powder for concentrate for solution for infusion | - One vial of powder contains 100 mg thiotepa. - After reconstitution with 10 mL of water for injections, each mL of solution contains 10 mg thiotepa (10 mg/mL). - - For the full list of excipients, see section 6.1. | Powder for concentrate for solution for infusion. White crystalline powder. | ADIENNE S.r.l. S.U. Via Galileo Galilei, 19 - 20867 Caponago (MB) Italy - Tel: +39-02 40700445 - adienne@adienne.com | PLGB 40008/0002 | Jan. 1, 2021 | Feb. 11, 2025 | See Details |
| 247 | SOMAC Control 20 mg gastro-resistant tablets | Each gastro-resistant tablet contains 20 mg pantoprazole (as sodium sesquihydrate). For the full list of excipients, see section 6.1. | Gastro-resistant tablet. Yellow, oval, biconvex film-coated tablets imprinted with “P20” in brown ink on one side. | Takeda GmbH Byk-Gulden-Str. 2 D-78467 Konstanz Germany Tel: +44 (0)3333 000181 medinfoEMEA@takeda.com | PLGB 31752/0037 | Jan. 1, 2021 | Dec. 10, 2023 | See Details |
| 244 | Pregabalin Accord 225 mg hard capsules | Each hard capsule contains 225 mg of pregabalin. For the full list of excipients, see section 6.1. | Hard capsule Orange opaque/ White opaque, size “1” hard gelatin capsules imprinted with ‘PG’ on cap and ‘225’ on body. Each capsule is approximately 19.3 mm in length. | Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex, HA1 4HF United Kingdom | PLGB 20075/1324 | Jan. 1, 2021 | July 22, 2024 | See Details |
| 243 | Rotarix oral suspension in pre-filled oral applicator Rotavirus vaccine, live | 1 dose (1.5 mL) contains: Human rotavirus RIX4414 strain (live, attenuated)* not less than 106.0 CCID50 *Produced on Vero cells Excipients with known effect: This product contains 1 073 mg of sucrose, 32 mg of sodium, 10 micrograms of glucose and 0.15 microgram of phenylalanine per dose (see section 4.4). For the full list of excipients, see section 6.1. | Oral suspension. Rotarix is a clear and colourless liquid. | GlaxoSmithKline UK Limited 79 New Oxford Street London WC1A 1DG United Kingdom | PLGB 19494/0320 | April 4, 2025 | See Details | |
| 242 | Bexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA, component, adsorbed) | One dose (0.5 ml) contains: Recombinant Neisseria meningitidis group B NHBA fusion protein 1, 2, 3 50 micrograms Recombinant Neisseria meningitidis group B NadA protein 1, 2, 3 50 micrograms Recombinant Neisseria meningitidis group B fHbp fusion protein 1, 2, 3 50 micrograms Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4 2 25 micrograms 1 produced in E. coli cells by recombinant DNA technology 2 adsorbed on aluminium hydroxide (0.5 mg Al³+) ³ NHBA (Neisserial Heparin Binding Antigen), NadA (Neisseria adhesin A), fHbp (factor H binding protein) For the full list of excipients, see section 6.1. | Suspension for injection. White opalescent liquid suspension. | GlaxoSmithKline UK Limited 79 New Oxford Street London WC1A 1DG United Kingdom Plunger Barrel Cap Luer Lock Adaptor Needle hub | PLGB 19494/0288 | Jan. 1, 2021 | April 25, 2025 | See Details |
| 241 | Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed). | 1 dose (0.5 ml) contains: Hepatitis B surface antigen 1, 2, 3 20 micrograms 1adjuvanted by AS04C containing: - 3-O-desacyl-4’- monophosphoryl lipid A (MPL) 2 50 micrograms 2adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology. For the full list of excipients, see section 6.1 | Suspension for injection. Turbid white suspension. Upon storage, a fine white deposit with a clear colourless supernatant can be observed. | GlaxoSmithKline UK Limited 79 New Oxford Street London WC1A 1DG Plunger Barrel Cap Luer Lock Adaptor Needle hub United Kingdom | PLGB 19494/0267 | Jan. 1, 2021 | April 25, 2025 | See Details |
| 240 | Twinrix Paediatric, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). | 1 dose (0.5 ml) contains: Hepatitis A virus (inactivated)1,2 360 ELISA Units Hepatitis B surface antigen3,4 10 micrograms 1Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated 0.025 milligrams Al3+ 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate 0.2 milligrams Al3+ The vaccine may contain traces of neomycin which is used during the manufacturing process (see section 4.3). For the full list of excipients, see section 6.1. | Suspension for injection. Turbid white suspension. | GlaxoSmithKline UK Limited 79 New Oxford Street Plunger Barrel Cap Luer Lock Adaptor Needle hub London WC1A 1DG United Kingdom | PLGB 19494/0266 | Jan. 1, 2021 | April 25, 2025 | See Details |
| 239 | Twinrix Adult, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). | 1 dose (1 ml) contains: Hepatitis A virus (inactivated)1,2 720 ELISA Units Hepatitis B surface antigen3,4 20 micrograms 1Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated 0.05 milligrams Al3+ 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate 0.4 milligrams Al3+ The vaccine may contain traces of neomycin which is used during the manufacturing process (see section 4.3). For the full list of excipients, see section 6.1. | Suspension for injection. Turbid white suspension. | GlaxoSmithKline UK Limited 79 New Oxford Street London WC1A 1DG United Kingdom | PLGB 19494/0265 | Jan. 1, 2021 | See Details | |
| 238 | Infanrix hexa, Powder and suspension for suspension for injection. Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed). | After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid1 not less than 30 International Units (IU) Tetanus toxoid1 not less than 40 International Units (IU) Bordetella pertussis antigens Pertussis toxoid (PT)1 25 micrograms Filamentous Haemagglutinin (FHA)1 25 micrograms Pertactin (PRN)1 8 micrograms Hepatitis B surface antigen (HBs)2,3 10 micrograms Poliovirus (inactivated) (IPV) type 1 (Mahoney strain)4 40 D-antigen unit type 2 (MEF-1 strain)4 8 D-antigen unit type 3 (Saukett strain)4 32 D-antigen unit Haemophilus influenzae type b polysaccharide 10 micrograms (polyribosylribitol phosphate, PRP) 3 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms 1adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 0.5 milligrams Al3+ 2produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 3adsorbed on aluminium phosphate (AlPO4) 0.32 milligrams Al3+ 4propagated in VERO cells The vaccine may contain traces of formaldehyde, neomycin and polymyxin which are used during the manufacturing process (see section 4.3). Excipients with known effect The vaccine contains para-aminobenzoic acid 0.057 nanograms per dose and phenylalanine 0.0298 micrograms per dose (see section 4.4). For the full list of excipients, see section 6.1. | Powder and suspension for suspension for injection. The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) component is a turbid white suspension. The lyophilised Haemophilus influenzae type b (Hib) component is a white powder. | GlaxoSmithKline UK Limited 79 New Oxford Street London WC1A 1DG United Kingdom | PLGB 19494/0261 | April 29, 2025 | See Details | |
| 237 | Ambirix, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). | 1 dose (1 ml) contains: Hepatitis A virus (inactivated)1,2 720 ELISA Units Hepatitis B surface antigen3,4 20 micrograms 1Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated 0.05 milligrams Al3+ 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate 0.4 milligrams Al3+ For the full list of excipients, see section 6.1. | Suspension for injection. Ambirix is a turbid white suspension. | GlaxoSmithKline UK Limited 79 New Oxford Street London WC1A 1DG United Kingdom | PLGB 19494/0259 | Jan. 1, 2021 | April 25, 2025 | See Details |
| 236 | Rotarix oral suspension in squeezable tube Rotavirus vaccine, live | 1 dose (1.5 mL) contains: Human rotavirus RIX4414 strain (live, attenuated)* not less than 106.0 CCID50 *Produced on Vero cells Excipients with known effect: This product contains 1 073 mg of sucrose, 32 mg of sodium, 10 micrograms of glucose and 0.15 microgram of phenylalanine per dose (see section 4.4). For the full list of excipients, see section 6.1. | Oral suspension. Rotarix is a clear and colourless liquid. | GlaxoSmithKline UK Limited 79 New Oxford Street London WC1A 1DG United Kingdom | PLGB 19494/0256 | Jan. 1, 2021 | April 4, 2025 | See Details |
| 235 | Fluenz nasal spray suspension Influenza vaccine (live, nasal) | Reassortant influenza virus* (live attenuated) of the following three strains**: A/ Victoria/4897/2022 (H1N1)pdm09 - like strain (A/ Norway/31694/2022, MEDI 369815) 107.0±0.5 FFU*** A/Croatia/10136RV/2023 (H3N2) - like strain (A/Perth/722/2024, MEDI 392611) 107.0±0.5 FFU*** B/ Austria/1359417/2021 - like strain (B/ Austria/1359417/2021, MEDI 355292) 107.0±0.5 FFU*** ..................................................................................................................per 0.2 ml dose * Propagated in fertilised hens’ eggs from healthy chicken flocks. ** Produced in VERO cells by reverse genetic technology. This product contains genetically modified organisms (GMOs). *** Fluorescent Focus Units. This vaccine complies with the WHO recommendation (Northern Hemisphere) and EU decision for the 2025/2026 season. The vaccine may contain traces of the following substances: egg proteins (e.g. ovalbumin) and gentamicin. The maximum amount of ovalbumin is less than 0.024 micrograms per 0.2 ml dose (0.12 micrograms per ml), see section 4.3. For the full list of excipients, see section 6.1. | Nasal spray suspension Colourless to pale yellow, clear to opalescent suspension with a pH of approximately 7.2. Small white particles may be present. | AstraZeneca UK Limited, 1 Francis Crick Avenue, Cambridge, CB2 0AA, UK | PLGB 17901/0378 | June 26, 2024 | July 21, 2025 | See Details |
| 234 | Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal) | Reassortant influenza virus* (live attenuated) of the following four strains**: A/Victoria/4897/2022 (H1N1)pdm09 - like strain (A/Norway/31694/2022, MEDI 369815) 107.0±0.5 FFU*** A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) 107.0±0.5 FFU*** B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) 107.0±0.5 FFU*** B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444) 107.0±0.5 FFU*** ..................................................................................................................per 0.2 ml dose * propagated in fertilised hens’ eggs from healthy chicken flocks. ** produced in VERO cells by reverse genetic technology. This product contains genetically modified organisms (GMOs). *** fluorescent focus units. This vaccine complies with the WHO recommendation (Northern Hemisphere) and EU decision for the 2023/2024 season. The vaccine may contain residues of the following substances: egg proteins (e.g. ovalbumin) and gentamicin. The maximum amount of ovalbumin is less than 0.024 micrograms per 0.2 ml dose (0.12 micrograms per ml). For the full list of excipients, see section 6.1. | Nasal spray, suspension The suspension is colourless to pale yellow, clear to opalescent with a pH of approximately 7.2. Small white particles may be present. | AstraZeneca UK Limited, 1 Francis Crick Avenue, Cambridge, CB2 0AA, UK. | PLGB 17901/0324 | Jan. 1, 2021 | July 18, 2023 | See Details |
| 233 | CEVENFACTA 5 mg (225 KIU) powder and solvent for solution for injection | Each vial contains nominally 5 mg eptacog beta (activated)(225 KIU/vial) corresponding to a concentration of approximately 1 mg/mL (45 KIU/mL) when reconstituted with 5.2 mL of water for injections. The potency (IU) is determined using a clotting assay. 1 KIU equals 1 000 IU (International Units). Eptacog beta (activated) is a recombinant coagulation Factor VIIa (rFVIIa) with a molecular mass of approximately 50 000 Daltons produced from rabbit milk by recombinant DNA technology. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection (vial: powder for injection; pre-filled syringe: water for injections). White to off-white lyophilised powder. Solvent: clear and colourless solution. The solution has a pH of approximately 6. The osmolality is approximately 290 mOsm/kg. | Laboratoire français du Fractionnement et des Biotechnologies Tour W 102 Terrasse Boieldieu, 19ème Étage 92800 Puteaux France | PLGB 17469/0013 | Aug. 19, 2022 | Aug. 19, 2022 | See Details |
| 232 | LIVTENCITY 200 mg film-coated tablets. | Each tablet contains 200 mg maribavir. For the full list of excipients, see section 6.1. | Film-coated tablet. Blue, oval shaped convex tablet of 15.5 mm, debossed with “SHP” on one side and “620” on the other side. | Takeda UK Ltd 1 Kingdom Street London W2 6BD United Kingdom E-mail: medinfoEMEA@takeda.com | PLGB 16189/0127 | Nov. 11, 2022 | June 24, 2025 | See Details |
| 231 | Qdenga powder and solvent for solution for injection in pre-filled syringe Dengue tetravalent vaccine (live, attenuated) | After reconstitution, 1 dose (0.5 mL) contains: Dengue virus serotype 1 (live, attenuated)*: = 3.3 log10 PFU**/dose Dengue virus serotype 2 (live, attenuated)#: = 2.7 log10 PFU**/dose Dengue virus serotype 3 (live, attenuated)*: = 4.0 log10 PFU**/dose Dengue virus serotype 4 (live, attenuated)*: = 4.5 log10 PFU**/dose *Produced in Vero cells by recombinant DNA technology. Genes of serotype-specific surface proteins engineered into dengue type 2 backbone. This product contains genetically modified organisms (GMOs). #Produced in Vero cells by recombinant DNA technology **PFU = Plaque-forming units For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. Prior to reconstitution, the vaccine is a white to off-white coloured freeze-dried powder (compact cake). The solvent is a clear, colourless solution. | Takeda UK Limited 1 Kingdom Street London W2 6BD United Kingdom | PLGB 16189/0126 | Jan. 26, 2023 | Nov. 5, 2025 | See Details |
| 230 | Qdenga powder and solvent for solution for injection Dengue tetravalent vaccine (live, attenuated) | After reconstitution, 1 dose (0.5 mL) contains: Dengue virus serotype 1 (live, attenuated)*: = 3.3 log10 PFU**/dose Dengue virus serotype 2 (live, attenuated)#: = 2.7 log10 PFU**/dose Dengue virus serotype 3 (live, attenuated)*: = 4.0 log10 PFU**/dose Dengue virus serotype 4 (live, attenuated)*: = 4.5 log10 PFU**/dose *Produced in Vero cells by recombinant DNA technology. Genes of serotype-specific surface proteins engineered into dengue type 2 backbone. This product contains genetically modified organisms (GMOs). #Produced in Vero cells by recombinant DNA technology **PFU = Plaque-forming units For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. Prior to reconstitution, the vaccine is a white to off-white coloured freeze-dried powder (compact cake). The solvent is a clear, colourless solution. | Takeda UK Limited 1 Kingdom Street London W2 6BD United Kingdom | PLGB 16189/0125 | Jan. 26, 2023 | Nov. 5, 2025 | See Details |
| 227 | Alogliptin 6.25 mg film-coated tablets | Alogliptin 6.25 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 6.25 mg alogliptin. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Alogliptin 6.25 mg film-coated tablets Light pink, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-6.25” printed in grey ink on one side. | Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark medinfoEMEA@takeda.com | PLGB 15475/0069 | Jan. 1, 2021 | Aug. 12, 2024 | See Details |
| 226 | Alogliptin 25 mg film-coated tablets | Alogliptin 25 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 25 mg alogliptin. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Alogliptin 25 mg film-coated tablets Light red, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-25” printed in grey ink on one side. | Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark medinfoEMEA@takeda.com | PLGB 15475/0068 | Jan. 1, 2021 | Aug. 12, 2024 | See Details |
| 225 | Alogliptin 12.5 mg film-coated tablets | Alogliptin 12.5 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Alogliptin 12.5 mg film-coated tablets Yellow, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-12.5” printed in grey ink on one side. | Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark medinfoEMEA@takeda.com | PLGB 15475/0067 | Jan. 1, 2021 | Aug. 12, 2024 | See Details |
| 224 | Alogliptin/Metformin Hydrochloride 12.5 mg/850 mg film-coated tablets | Each tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 850 mg metformin hydrochloride. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Light yellow, oblong (approximately 21.0 mm long by 10.1 mm wide), biconvex, film-coated tablets with “12.5/850” debossed on one side and “322M” debossed on the other side. | Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark | PLGB 15475/0066 | Jan. 1, 2021 | June 20, 2025 | See Details |
| 223 | Alogliptin/Metformin Hydrochloride 12.5 mg/1000 mg film-coated tablets | Each tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 1000 mg metformin hydrochloride. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Pale yellow, oblong (approximately 22.3 mm long by 10.7 mm wide), biconvex, film-coated tablets with “12.5/1000” debossed on one side and “322M” debossed on the other side. | Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark | PLGB 15475/0065 | Jan. 1, 2021 | Nov. 12, 2024 | See Details |
| 222 | Ixazomib 4 mg hard capsules | Ixazomib 4 mg hard capsules Each capsule contains 4 mg of ixazomib (as 5.7 mg of ixazomib citrate) For the full list of excipients, see section 6.1. | Hard capsule. Ixazomib 4 mg hard capsules Light orange, size 3 gelatin hard capsule, marked “Takeda” on the cap and “4 mg” on the body with black ink. | Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark medinfoEMEA@takeda.com | PLGB 15475/0061 | June 6, 2023 | July 18, 2025 | See Details |
| 221 | Ixazomib 3 mg hard capsules | Ixazomib 3 mg hard capsules Each capsule contains 3 mg of ixazomib (as 4.3 mg of ixazomib citrate) For the full list of excipients, see section 6.1. | Hard capsule. Ixazomib 3 mg hard capsules Light grey, size 4 gelatin hard capsule, marked “Takeda” on the cap and “3 mg” on the body with black ink. | Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark medinfoEMEA@takeda.com | PLGB 15475/0060 | June 6, 2023 | July 18, 2025 | See Details |
| 220 | Ixazomib 2.3 mg hard capsules | Ixazomib 2.3 mg hard capsules Each capsule contains 2.3 mg of ixazomib (as 3.3 mg of ixazomib citrate) For the full list of excipients, see section 6.1. | Hard capsule. Ixazomib 2.3 mg hard capsules Light pink, size 4 gelatin hard capsule, marked “Takeda” on the cap and “2.3 mg” on the body with black ink. | Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark medinfoEMEA@takeda.com | PLGB 15475/0059 | June 6, 2023 | July 18, 2025 | See Details |
| 219 | Incresync 25 mg/45 mg film-coated tablets | Incresync 25 mg/45 mg film-coated tablets Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone. Excipient(s) with known effect Each tablet contains 105 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Incresync 25 mg/45 mg film-coated tablets Red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “25/45” printed in grey ink on one side. | Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark | PLGB 15475/0052 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 218 | Incresync 25 mg/30 mg film-coated tablets | Incresync 25 mg/30 mg film-coated tablets Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 30 mg pioglitazone. Excipient(s) with known effect Each tablet contains 121 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Incresync 25 mg/30 mg film-coated tablets Peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “25/30” printed in grey ink on one side. | Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark | PLGB 15475/0051 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 217 | Incresync 12.5 mg/30 mg film-coated tablets | Incresync 12.5 mg/30 mg film-coated tablets Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone. Excipient(s) with known effect Each tablet contains 121 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Incresync 12.5 mg/30 mg film-coated tablets Pale peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “12.5/30” printed in red ink on one side. | Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark | PLGB 15475/0049 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 215 | Edarbi 80 mg tablets | Edarbi 80 mg tablets Each tablet contains 80 mg of azilsartan medoxomil (as potassium). For the full list of excipients, see section 6.1. | Tablet. Edarbi 80 mg tablets White to nearly white round tablets, 9.6 mm in diameter, debossed “ASL” on one side and “80” on the other. | Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark | PLGB 15475/0043 | Jan. 1, 2021 | March 10, 2025 | See Details |
| 214 | Edarbi 40 mg tablets | Edarbi 40 mg tablets Each tablet contains 40 mg of azilsartan medoxomil (as potassium). For the full list of excipients, see section 6.1. | Tablet. Edarbi 40 mg tablets White to nearly white round tablets, 7.6 mm in diameter, debossed “ASL” on one side and “40” on the other. | Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark | PLGB 15475/0042 | Jan. 1, 2021 | March 10, 2025 | See Details |
| 213 | Edarbi 20 mg tablets | Edarbi 20 mg tablets Each tablet contains 20 mg of azilsartan medoxomil (as potassium). | Tablet. Edarbi 20 mg tablets White to nearly white round tablets, 6.0 mm in diameter, debossed “ASL” on one side and “20” on the other. | Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark | PLGB 15475/0041 | Jan. 1, 2021 | March 10, 2025 | See Details |
| 212 | Alunbrig 180 mg film-coated tablets | Alunbrig 180 mg film-coated tablets Each film-coated tablet contains 180 mg of brigatinib. Excipient with known effect Each film-coated tablet contains 336 mg of lactose monohydrate. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Alunbrig 180 mg film-coated tablets Oval, white to off-white film-coated tablet of approximately 19 mm in length with debossed “U13” on one side and plain on the other side. | Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark | PLGB 15475/0039 | July 24, 2023 | May 29, 2024 | See Details |
| 211 | Alunbrig 90 mg film-coated tablets | Alunbrig 90 mg film-coated tablets Each film-coated tablet contains 90 mg of brigatinib. Excipient with known effect Each film-coated tablet contains 168 mg of lactose monohydrate. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Alunbrig 90 mg film-coated tablets Oval, white to off-white film-coated tablet of approximately 15 mm in length with debossed “U7” on one side and plain on the other side. | Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark | PLGB 15475/0038 | July 24, 2023 | May 29, 2024 | See Details |
| 210 | Alunbrig 30 mg film-coated tablets | Each film-coated tablet contains 30 mg of brigatinib. Excipient with known effect Each film-coated tablet contains 56 mg of lactose monohydrate. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). Round, white to off-white film-coated tablet of approximately 7 mm in diameter with debossed “U3” on one side and plain on the other side. | Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark | PLGB 15475/0037 | July 24, 2023 | May 29, 2024 | See Details |
| 209 | Alofisel 5 x 106 cells/mL dispersion for injection | General description Alofisel (darvadstrocel) is expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (expanded adipose stem cells - eASC). Each vial contains 30 x 106 cells (eASC) in 6 mL, of dispersion, corresponding to a concentration of 5 x 106 cells/mL. For the full list of excipients, see section 6.1. | Dispersion for injection (injection). The dispersion of cells may have settled in the bottom of the vial forming a sediment. After gentle re-suspension, the product is a white to yellowish homogeneous dispersion. | Takeda Pharma A/S Delta Park 45 Vallensbaek Strand DK-2665 Denmark | PLGB 15475/0036 | Jan. 1, 2021 | Feb. 12, 2024 | See Details |
| 208 | Viramune 50 mg/5 mL oral suspension | Each mL of oral suspension contains 10 mg of nevirapine (as hemihydrate). Each bottle contains 2.4 g of nevirapine (as hemihydrate) in 240 mL of Viramune oral suspension. Excipients with known effect Each mL of oral suspension contains 150 mg sucrose, 162 mg sorbitol, 1.8 mg of methyl parahydroxybenzoate and 0.24 mg of propyl parahydroxybenzoate. This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’. For the full list of excipients, see section 6.1. | Oral suspension White to off-white homogenous suspension. | Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein, Germany | PLGB 14598/0229 | Jan. 1, 2021 | Feb. 10, 2025 | See Details |
| 207 | TEPMETKO 225 mg film-coated tablets | Each film-coated tablet contains 225 mg tepotinib (as hydrochloride hydrate). Excipient with known effect Each film-coated tablet contains 4.15 mg lactose. For the full list of excipients, see section 6.1. | Film-coated tablet. White-pink, oval, biconvex film-coated tablet of approximately 18 mm in length with embossment ‘M’ on one side and plain on the other side. | Merck Serono Ltd 5 New Square Bedfont Lakes Business Park Feltham Middlesex TW14 8HA UK | PLGB 11648/0291 | July 1, 2025 | July 1, 2025 | See Details |
| 206 | Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in pre-filled pen | Each multidose pre-filled pen contains 450 IU (equivalent to 33 micrograms) of follitropin alfa* (r-hFSH) and 225 IU (equivalent to 9 micrograms) of lutropin alfa* (r-hLH) in 0.72 mL solution. *recombinant human follitropin alfa and recombinant human lutropin alfa are produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection (injection). Clear, colourless to slightly yellow solution. The pH of the solution is 6.5 to 7.5, its osmolality is 250 to 400 mOsm/kg. | Merck Serono Ltd 5 New Square Bedfont Lakes Business Park Feltham Middlesex TW14 8HA UK | PLGB 11648/0276 | Jan. 1, 2021 | July 5, 2023 | See Details |
| 205 | Thiotepa medac 100 mg powder for concentrate for solution for infusion | Thiotepa medac 100 mg One vial of powder contains 100 mg thiotepa. After reconstitution with 10 ml of water for injections, each ml of solution contains 10 mg thiotepa (10 mg/ml). For the full list of excipients, see section 6.1. | Powder for concentrate for solution for infusion. White crystalline powder. | medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6 22880 Wedel Germany Tel.: +49 4103 8006-0 Fax: +49 4103 8006-100 | PLGB 11587/0133 | Sept. 8, 2023 | March 5, 2024 | See Details |
| 204 | Thiotepa medac 15 mg powder for concentrate for solution for infusion | Thiotepa medac 15 mg One vial of powder contains 15 mg thiotepa. After reconstitution with 1.5 ml of water for injections, each ml of solution contains 10 mg thiotepa (10 mg/ml). For the full list of excipients, see section 6.1. | Powder for concentrate for solution for infusion. White crystalline powder. | medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6 22880 Wedel Germany Tel.: +49 4103 8006-0 Fax: +49 4103 8006-100 | PLGB 11587/0132 | Sept. 8, 2023 | March 5, 2024 | See Details |
| 203 | Thiotepa Fresenius Kabi 100 mg powder for concentrate for solution for infusion | Thiotepa Fresenius Kabi 100 mg powder for concentrate for solution for infusion One vial of powder contains 100 mg thiotepa. After reconstitution with 10 ml of water for injections, each ml of solution contains 10 mg thiotepa (10 mg/ml). For the full list of excipients, see section 6.1. | Powder for concentrate for solution for infusion. White powder or cake | Fresenius Kabi Ltd Cestrian Court Eastgate Way, Manor Park Runcorn, Cheshire, WA7 1NT United Kingdom | PLGB 08828/0363 | March 5, 2024 | Oct. 15, 2025 | See Details |
| 201 | Cinryze 500 IU powder and solvent for solution for injection | Each single-use powder vial contains 500 International Units (IU) of human C1- esterase inhibitor produced from the plasma of human donors. After reconstitution, one vial contains 500 IU of human C1-esterase inhibitor per 5 ml corresponding to a concentration of 100 IU/ml. One IU is equivalent to the amount of C1-esterase inhibitor present in 1 ml of normal human plasma. The total protein content of the reconstituted solution is 15 ± 5 mg/ml. Excipient with known effect Each vial of Cinryze contains approximately 11.5 mg of sodium. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. White powder. The solvent is a clear, colourless solution. | Takeda Manufacturing Austria AG Industriestrasse 67 1221 Vienna Austria | PLGB 06009/0036 | Jan. 1, 2021 | June 30, 2025 | See Details |
| 200 | KIOVIG 100 mg/ml solution for infusion | Human normal immunoglobulin (IVIg) One ml contains: Human normal immunoglobulin ……………100 mg (purity of at least 98% IgG) Each vial of 10 ml contains: 1 g of human normal immunoglobulin Each vial of 25 ml contains: 2.5 g of human normal immunoglobulin Each vial of 50 ml contains: 5 g of human normal immunoglobulin Each vial of 100 ml contains: 10 g of human normal immunoglobulin Each vial of 200 ml contains: 20 g of human normal immunoglobulin Each vial of 300 ml contains: 30 g of human normal immunoglobulin Distribution of IgG subclasses (approx. values): IgG1 =56.9% IgG2 =26.6% IgG3 =3.4% IgG4 =1.7% The maximum IgA content is 140 micrograms/ml. Produced from the plasma of human donors. For the full list of excipients, see section 6.1. | Solution for infusion The solution is clear or slightly opalescent and colourless or pale yellow. | Takeda Manufacturing Austria AG Industriestrasse 67 A-1221 Vienna, Austria | PLGB 06009/0035 | Jan. 1, 2021 | April 8, 2022 | See Details |
| 199 | CEPROTIN 500 IU powder and solvent for solution for injection | Protein C from human plasma purified by mouse monoclonal antibodies. CEPROTIN 500 IU* is prepared as a powder containing nominally 500 IU human protein C per container. The product reconstituted with 5 ml of Sterilised Water for Injections contains approximately 100 IU/ml human protein C. The potency (IU) is determined using a chromogenic substrate method against the World Health Organisation (WHO) International standard. *One International Unit (IU) of protein C corresponds to the amidolytically measured activity of protein C in 1 ml of normal plasma. Excipients with known effect: This medicinal product contains 22.5 mg sodium per vial. For the full list of excipients see section 6.1. | Human protein C, powder and solvent for solution for injection. Lyophilised white or cream coloured powder or friable solid. After reconstitution the solution has a pH of between 6.7 and 7.3 and an osmolality of not lower than 240 mosmol/kg. | Takeda Manufacturing Austria AG Industriestrasse 67 1221 Vienna Austria | PLGB 06009/0034 | Jan. 1, 2021 | Jan. 12, 2023 | See Details |
| 198 | CEPROTIN 1,000 IU powder and solvent for solution for injection | Protein C from human plasma purified by mouse monoclonal antibodies. CEPROTIN 1,000 IU* is prepared as a powder containing nominally 1,000 IU human protein C per container. The product reconstituted with 10 ml of Sterilised Water for Injections contains approximately 100 IU/ml human protein C. The potency (IU) is determined using a chromogenic substrate method against the World Health Organisation (WHO) International standard. *One International Unit (IU) of protein C corresponds to the amidolytically measured activity of protein C in 1 ml of normal plasma. Excipients with known effect: This medicinal product contains 44.9 mg sodium per vial. For the full list of excipients see section 6.1. | Human protein C, powder and solvent for solution for injection. Lyophilised white or cream coloured powder or friable solid. After reconstitution the solution has a pH of between 6.7 and 7.3 and an osmolality of not lower than 240 mosmol/kg. | Takeda Manufacturing Austria AG Industriestrasse 67 1221 Vienna Austria | PLGB 06009/0033 | Jan. 1, 2021 | Jan. 12, 2023 | See Details |
| 197 | ADVATE 250 IU/2 ml powder and solvent for solution for injection. ADVATE 500 IU/2 ml powder and solvent for solution for injection. ADVATE 1 000/2 ml IU powder and solvent for solution for injection. ADVATE 1 500/2ml IU powder and solvent for solution for injection. | ADVATE 250 IU/2 ml powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 125 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 2 ml solvent. ADVATE 500 IU/2 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 250 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 2 ml solvent. ADVATE 1 000 IU/2 ml powder and solvent for solution for injection Each vial contains nominally 1 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 500 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 2 ml solvent. ADVATE 1 500 IU/2 ml powder and solvent for solution for injection Each vial contains nominally 1 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 750 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 2 ml solvent. The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of ADVATE is approximately 4 520-11 300 IU/mg protein. Octocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids. It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Prepared without the addition of any (exogenous) human- or animal-derived protein in the cell culture process, purification or final formulation. Excipients with known effect This medicinal product contains 0.45 mmol sodium (10 mg) and 0.5 mg polysorbate 80 per vial. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. Powder: White to off-white friable powder. Solvent: Clear and colourless solution. After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.7 to 7.3. | Takeda Manufacturing Austria AG Industriestrasse 67 A-1221 Vienna, Austria | PLGB 06009/0032 | Jan. 1, 2021 | July 10, 2025 | See Details |
| 196 | ADVATE 250 IU/5 ml powder and solvent for solution for injection. ADVATE 500 IU/5 ml powder and solvent for solution for injection. ADVATE 1 000 IU/5 ml powder and solvent for solution for injection. ADVATE 1 500 IU/5 ml powder and solvent for solution for injection. ADVATE 2 000 IU/ 5 ml powder and solvent for solution for injection. ADVATE 3 000 IU/5 ml powder and solvent for solution for injection. | ADVATE 250 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 50 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 500 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 100 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 1 000 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 1 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 200 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 1 500 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 1 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 300 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 2 000 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 2 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 400 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 3 000 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 3 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 600 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of ADVATE is approximately 4 520-11 300 IU/mg protein. Octocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids. It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Prepared without the addition of any (exogenous) human- or animal-derived protein in the cell culture process, purification or final formulation. Excipients with known effect: This medicinal product contains 0.45 mmol sodium (10 mg) and 0.5 mg polysorbate 80 per vial. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. Powder: White to off-white friable powder. Solvent: Clear and colourless solution. After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.7 to 7.3. | Takeda Manufacturing Austria AG Industriestrasse 67 A-1221 Vienna, Austria | PLGB 06009/0031 | Jan. 1, 2021 | July 10, 2025 | See Details |
| 195 | ADVATE 250 IU/5 ml powder and solvent for solution for injection. ADVATE 500 IU/5 ml powder and solvent for solution for injection. ADVATE 1 000 IU/5 ml powder and solvent for solution for injection. ADVATE 1 500 IU/5 ml powder and solvent for solution for injection. ADVATE 2 000 IU/ 5 ml powder and solvent for solution for injection. ADVATE 3 000 IU/5 ml powder and solvent for solution for injection. | ADVATE 250 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 50 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 500 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 100 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 1 000 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 1 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 200 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 1 500 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 1 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 300 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 2 000 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 2 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 400 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 3 000 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 3 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 600 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of ADVATE is approximately 4 520-11 300 IU/mg protein. Octocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids. It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Prepared without the addition of any (exogenous) human- or animal-derived protein in the cell culture process, purification or final formulation. Excipients with known effect: This medicinal product contains 0.45 mmol sodium (10 mg) and 0.5 mg polysorbate 80 per vial. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. Powder: White to off-white friable powder. Solvent: Clear and colourless solution. After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.7 to 7.3. | Takeda Manufacturing Austria AG Industriestrasse 67 A-1221 Vienna, Austria | PLGB 06009/0030 | Jan. 1, 2021 | July 10, 2025 | See Details |
| 194 | ADVATE 250 IU/5 ml powder and solvent for solution for injection. ADVATE 500 IU/5 ml powder and solvent for solution for injection. ADVATE 1 000 IU/5 ml powder and solvent for solution for injection. ADVATE 1 500 IU/5 ml powder and solvent for solution for injection. ADVATE 2 000 IU/ 5 ml powder and solvent for solution for injection. ADVATE 3 000 IU/5 ml powder and solvent for solution for injection. | ADVATE 250 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 50 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 500 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 100 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 1 000 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 1 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 200 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 1 500 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 1 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 300 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 2 000 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 2 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 400 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 3 000 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 3 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 600 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of ADVATE is approximately 4 520-11 300 IU/mg protein. Octocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids. It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Prepared without the addition of any (exogenous) human- or animal-derived protein in the cell culture process, purification or final formulation. Excipients with known effect: This medicinal product contains 0.45 mmol sodium (10 mg) and 0.5 mg polysorbate 80 per vial. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. Powder: White to off-white friable powder. Solvent: Clear and colourless solution. After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.7 to 7.3. | Takeda Manufacturing Austria AG Industriestrasse 67 A-1221 Vienna, Austria | PLGB 06009/0029 | Jan. 1, 2021 | July 10, 2025 | See Details |
| 193 | ADVATE 250 IU/2 ml powder and solvent for solution for injection. ADVATE 500 IU/2 ml powder and solvent for solution for injection. ADVATE 1 000/2 ml IU powder and solvent for solution for injection. ADVATE 1 500/2ml IU powder and solvent for solution for injection. | ADVATE 250 IU/2 ml powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 125 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 2 ml solvent. ADVATE 500 IU/2 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 250 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 2 ml solvent. ADVATE 1 000 IU/2 ml powder and solvent for solution for injection Each vial contains nominally 1 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 500 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 2 ml solvent. ADVATE 1 500 IU/2 ml powder and solvent for solution for injection Each vial contains nominally 1 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 750 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 2 ml solvent. The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of ADVATE is approximately 4 520-11 300 IU/mg protein. Octocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids. It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Prepared without the addition of any (exogenous) human- or animal-derived protein in the cell culture process, purification or final formulation. Excipients with known effect This medicinal product contains 0.45 mmol sodium (10 mg) and 0.5 mg polysorbate 80 per vial. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. Powder: White to off-white friable powder. Solvent: Clear and colourless solution. After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.7 to 7.3. | Takeda Manufacturing Austria AG Industriestrasse 67 A-1221 Vienna, Austria | PLGB 06009/0028 | Jan. 1, 2021 | July 10, 2025 | See Details |
| 192 | ADVATE 250 IU/5 ml powder and solvent for solution for injection. ADVATE 500 IU/5 ml powder and solvent for solution for injection. ADVATE 1 000 IU/5 ml powder and solvent for solution for injection. ADVATE 1 500 IU/5 ml powder and solvent for solution for injection. ADVATE 2 000 IU/ 5 ml powder and solvent for solution for injection. ADVATE 3 000 IU/5 ml powder and solvent for solution for injection. | ADVATE 250 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 50 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 500 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 100 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 1 000 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 1 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 200 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 1 500 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 1 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 300 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 2 000 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 2 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 400 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 3 000 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 3 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 600 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of ADVATE is approximately 4 520-11 300 IU/mg protein. Octocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids. It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Prepared without the addition of any (exogenous) human- or animal-derived protein in the cell culture process, purification or final formulation. Excipients with known effect: This medicinal product contains 0.45 mmol sodium (10 mg) and 0.5 mg polysorbate 80 per vial. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. Powder: White to off-white friable powder. Solvent: Clear and colourless solution. After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.7 to 7.3. | Takeda Manufacturing Austria AG Industriestrasse 67 A-1221 Vienna, Austria | PLGB 06009/0027 | Jan. 1, 2021 | July 10, 2025 | See Details |
| 191 | ADVATE 250 IU/2 ml powder and solvent for solution for injection. ADVATE 500 IU/2 ml powder and solvent for solution for injection. ADVATE 1 000/2 ml IU powder and solvent for solution for injection. ADVATE 1 500/2ml IU powder and solvent for solution for injection. | ADVATE 250 IU/2 ml powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 125 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 2 ml solvent. ADVATE 500 IU/2 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 250 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 2 ml solvent. ADVATE 1 000 IU/2 ml powder and solvent for solution for injection Each vial contains nominally 1 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 500 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 2 ml solvent. ADVATE 1 500 IU/2 ml powder and solvent for solution for injection Each vial contains nominally 1 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 750 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 2 ml solvent. The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of ADVATE is approximately 4 520-11 300 IU/mg protein. Octocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids. It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Prepared without the addition of any (exogenous) human- or animal-derived protein in the cell culture process, purification or final formulation. Excipients with known effect This medicinal product contains 0.45 mmol sodium (10 mg) and 0.5 mg polysorbate 80 per vial. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. Powder: White to off-white friable powder. Solvent: Clear and colourless solution. After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.7 to 7.3. | Takeda Manufacturing Austria AG Industriestrasse 67 A-1221 Vienna, Austria | PLGB 06009/0026 | Jan. 1, 2021 | July 10, 2025 | See Details |
| 190 | ADVATE 250 IU/5 ml powder and solvent for solution for injection. ADVATE 500 IU/5 ml powder and solvent for solution for injection. ADVATE 1 000 IU/5 ml powder and solvent for solution for injection. ADVATE 1 500 IU/5 ml powder and solvent for solution for injection. ADVATE 2 000 IU/ 5 ml powder and solvent for solution for injection. ADVATE 3 000 IU/5 ml powder and solvent for solution for injection. | ADVATE 250 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 50 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 500 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 100 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 1 000 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 1 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 200 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 1 500 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 1 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 300 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 2 000 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 2 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 400 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 3 000 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 3 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 600 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of ADVATE is approximately 4 520-11 300 IU/mg protein. Octocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids. It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Prepared without the addition of any (exogenous) human- or animal-derived protein in the cell culture process, purification or final formulation. Excipients with known effect: This medicinal product contains 0.45 mmol sodium (10 mg) and 0.5 mg polysorbate 80 per vial. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. Powder: White to off-white friable powder. Solvent: Clear and colourless solution. After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.7 to 7.3. | Takeda Manufacturing Austria AG Industriestrasse 67 A-1221 Vienna, Austria | PLGB 06009/0025 | Jan. 1, 2021 | July 10, 2025 | See Details |
| 189 | ADVATE 250 IU/5 ml powder and solvent for solution for injection. ADVATE 500 IU/5 ml powder and solvent for solution for injection. ADVATE 1 000 IU/5 ml powder and solvent for solution for injection. ADVATE 1 500 IU/5 ml powder and solvent for solution for injection. ADVATE 2 000 IU/ 5 ml powder and solvent for solution for injection. ADVATE 3 000 IU/5 ml powder and solvent for solution for injection. | ADVATE 250 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 50 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 500 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 100 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 1 000 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 1 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 200 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 1 500 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 1 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 300 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 2 000 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 2 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 400 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. ADVATE 3 000 IU/5 ml powder and solvent for solution for injection Each vial contains nominally 3 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 600 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 5 ml solvent. The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of ADVATE is approximately 4 520-11 300 IU/mg protein. Octocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids. It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Prepared without the addition of any (exogenous) human- or animal-derived protein in the cell culture process, purification or final formulation. Excipients with known effect: This medicinal product contains 0.45 mmol sodium (10 mg) and 0.5 mg polysorbate 80 per vial. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. Powder: White to off-white friable powder. Solvent: Clear and colourless solution. After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.7 to 7.3. | Takeda Manufacturing Austria AG Industriestrasse 67 A-1221 Vienna, Austria | PLGB 06009/0024 | Jan. 1, 2021 | July 10, 2025 | See Details |
| 188 | ADVATE 250 IU/2 ml powder and solvent for solution for injection. ADVATE 500 IU/2 ml powder and solvent for solution for injection. ADVATE 1 000/2 ml IU powder and solvent for solution for injection. ADVATE 1 500/2ml IU powder and solvent for solution for injection. | ADVATE 250 IU/2 ml powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 125 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 2 ml solvent. ADVATE 500 IU/2 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 250 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 2 ml solvent. ADVATE 1 000 IU/2 ml powder and solvent for solution for injection Each vial contains nominally 1 000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 500 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 2 ml solvent. ADVATE 1 500 IU/2 ml powder and solvent for solution for injection Each vial contains nominally 1 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 750 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution with 2 ml solvent. The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of ADVATE is approximately 4 520-11 300 IU/mg protein. Octocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids. It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Prepared without the addition of any (exogenous) human- or animal-derived protein in the cell culture process, purification or final formulation. Excipients with known effect This medicinal product contains 0.45 mmol sodium (10 mg) and 0.5 mg polysorbate 80 per vial. For the full list of excipients, see section 6.1. | Powder and solvent for solution for injection. Powder: White to off-white friable powder. Solvent: Clear and colourless solution. After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.7 to 7.3. | Takeda Manufacturing Austria AG Industriestrasse 67 A-1221 Vienna, Austria | PLGB 06009/0023 | Jan. 1, 2021 | July 10, 2025 | See Details |
| 187 | Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen | Each mL of the solution contains 600 IU (equivalent to 44 micrograms) of follitropin alfa*. Each pre-filled pen delivers 225 IU (equivalent to 16.5 micrograms) in 0.375 mL. * recombinant human follicle stimulating hormone (r-hFSH) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection (injection). Clear colourless solution. The pH of the solution is 6.7 to 7.3. | Gedeon Richter Plc. Gyömroi út 19-21. 1103 Budapest Hungary | PLGB 04854/0168 | Jan. 1, 2021 | June 30, 2025 | See Details |
| 186 | Enzalutamide 40 mg film-coated tablets | Each film-coated tablet contains 40 mg of enzalutamide. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet) Yellow, round, film-coated tablets, debossed with “40” on one side, with a diameter of approximately 10 mm | Generics UK Ltd t/a Mylan Station Close Potters Bar Hertfordshire EN6 1TL UK | PLGB 04569/2085 | Nov. 18, 2024 | Aug. 21, 2025 | See Details |
| 185 | Dimethyl fumarate Mylan 240 mg gastro-resistant hard capsules | Each gastro-resistant hard capsule contains 240 mg dimethyl fumarate For the full list of excipients, see section 6.1. | Gastro-resistant hard capsule (gastro-resistant capsule) Dimethyl fumarate Mylan 240 mg gastro-resistant hard capsules Blue-green gastro-resistant hard capsules, 23.5 mm in length, printed with ‘MYLAN’ over ‘DF 240’ containing white to off-white enteric coated pellets. | Generics [UK] Ltd t/a Mylan Potters Bar, Herts, EN6 1TL | PLGB 04569/2075 | Sept. 1, 2025 | See Details | |
| 184 | Lenalidomide Mylan 15mg hard capsules | Each capsule contains 15 mg of lenalidomide. For the full list of excipients, see section 6.1. | Hard capsule (capsule). White capsules, size 0, 22 mm, marked “MYLAN/LL15”. | Generics [UK] Limited t/a Mylan Potters Bar EN6 1TL United Kingdom | PLGB 04569/2052 | Jan. 1, 2021 | Sept. 30, 2024 | See Details |
| 183 | Deferasirox Mylan 360 mg film-coated tablets | Each film-coated tablet contains 360 mg deferasirox. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet) A blue, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF 2’ on the other side. Approximate tablet dimensions 17 mm × 6.7 mm. | Generics (UK) Limited t/a Mylan Station Close, Potters Bar, EN6 1TL, United Kingdom | PLGB 04569/2026 | Oct. 4, 2023 | See Details | |
| 182 | Deferasirox Mylan 180 mg film-coated tablets | Each film-coated tablet contains 180 mg deferasirox. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet) A blue, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF 1’ on the other side. Approximate tablet dimensions 12.8 mm × 6.00 mm. | Generics (UK) Limited t/a Mylan Station Close, Potters Bar, EN6 1TL, United Kingdom | PLGB 04569/2025 | Oct. 4, 2023 | See Details | |
| 181 | Deferasirox Mylan 90 mg film-coated tablets | Each film-coated tablet contains 90 mg deferasirox. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet) A blue, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF’ on the other side. Approximate tablet dimensions 10.00 mm × 4.5 mm. | Generics (UK) Limited t/a Mylan Station Close, Potters Bar, EN6 1TL, United Kingdom | PLGB 04569/2024 | Oct. 4, 2023 | See Details | |
| 180 | Zonisamide Mylan 100 mg hard capsules | Each hard capsule contains 100 mg of zonisamide. For the full list of excipients, see section 6.1. | Hard capsule. A white opaque body and a white opaque cap, marked ‘Z 100’ in black containing white/almost white powder. Each hard capsule is approximately 19.3 mm in length. | Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, EN6 1TL, United Kingdom. | PLGB 04569/2023 | Jan. 1, 2021 | Aug. 15, 2023 | See Details |
| 179 | Zonisamide Mylan 50 mg hard capsules | Each hard capsule contains 50 mg of zonisamide. For the full list of excipients, see section 6.1. | Hard capsule. A white opaque body and a white opaque cap, marked ‘Z 50’ in red containing white/almost white powder. Each hard capsule is approximately 15.8 mm in length. | Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, EN6 1TL, United Kingdom. | PLGB 04569/2022 | Jan. 1, 2021 | Aug. 15, 2023 | See Details |
| 178 | Zonisamide Mylan 25 mg hard capsules | Each hard capsule contains 25 mg of zonisamide. For the full list of excipients, see section 6.1. | Hard capsule. A white opaque body and a white opaque cap, marked ‘Z 25’ in black containing white/almost white powder. Each hard capsule is approximately 14.4 mm in length. | Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, EN6 1TL, United Kingdom. | PLGB 04569/2021 | Jan. 1, 2021 | Aug. 15, 2023 | See Details |
| 177 | Tadalafil Mylan 5 mg film-coated tablets | Each tablet contains 5 mg tadalafil. Excipient with known effect: Each film-coated tablet contains 59.48 mg of lactose. For the full list of excipients, see section 6.1. | Film-coated tablet (tablet). A light yellow, film-coated, round, biconvex tablet (6.3 ± 0.3 mm) debossed with ‘M’ on one side of the tablet and ‘TL over 2’ on the other side. | Generics [UK] Limited t/a Mylan Potters Bar EN6 1TL United Kingdom | PLGB 04569/2015 | Jan. 1, 2021 | Jan. 10, 2024 | See Details |
| 176 | Rixathon 500 mg concentrate for solution for infusion | Each 50 mL vial contains 500 mg of rituximab. Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences. The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures. Excipient with known effect Each 50 mL vial contains 11.5 mmol (263.2 mg) sodium. Each 50 mL vial contains 35.0 mg of polysorbate 80 (E 433). For the full list of excipients, see section 6.1. | Concentrate for solution for infusion. Clear, colourless to slightly yellowish liquid with pH of 6.3 – 6.7 and osmolality of = 240 mOsm/kg. | Sandoz GmbH Biochemiestr. 10 6250 Kundl Austria | PLGB 04520/0226 | Dec. 10, 2024 | Aug. 1, 2025 | See Details |
| 175 | Rixathon 100 mg concentrate for solution for infusion | Each 10 mL vial contains 100 mg of rituximab. Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences. The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures. Excipient with known effect Each 10 mL vial contains 2.3 mmol (52.6 mg) sodium. Each 10 mL vial contains 7.0 mg of polysorbate 80 (E 433). For the full list of excipients, see section 6.1. | Concentrate for solution for infusion. Clear, colourless to slightly yellowish liquid with pH of 6.3 – 6.7 and osmolality of = 240 mOsm/kg. | Sandoz GmbH Biochemiestr. 10 6250 Kundl Austria | PLGB 04520/0225 | Dec. 10, 2024 | Aug. 1, 2025 | See Details |
| 174 | Supemtek TIVr, solution for injection in pre-filled syringe Trivalent Influenza Vaccine (recombinant, prepared in cell culture) | One dose (0.5 mL) contains: Influenza virus haemagglutinin (HA) proteins, of the following strains*: A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/West Virginia/30/2022)..............................................................45 micrograms HA A/District of Columbia/27/2023 (H3N2)-like strain (A/District of Columbia/27/2023)...................................................45 micrograms HA B/Austria/1359417/2021-like strain (B/Austria/1359417/2021).................................................................45 micrograms HA * produced by recombinant DNA technology using a baculovirus expression system in a continuous insect cell line that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda. This vaccine complies with the World Health Organization (WHO) recommendation (Northern Hemisphere) and EU recommendation for the 2025/2026 season. Supemtek TIVr may contain traces of octylphenol ethoxylate. For the full list of excipients, see section 6.1. | Solution for injection in pre-filled syringe (injection). Clear and colourless solution. | Aventis Pharma Limited 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK Trading as: Sanofi 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK | PLGB 04425/0909 | March 25, 2025 | Jan. 20, 2026 | See Details |
| 173 | Supemtek solution for injection in pre-filled syringe Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture) | One dose (0.5 mL) contains: Influenza virus haemagglutinin (HA) proteins, of the following strains*: A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/West Virginia/30/2022)..................................................45 micrograms HA A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/6/2021)...............................................................45 micrograms HA B/Austria/1359417/2021-like strain (B/Austria/1359417/2021) .........................................................................45 micrograms HA B/Phuket/3073/2013-like strain (B/Phuket/3073/2013)..........................................................45 micrograms HA * produced by recombinant DNA technology using a baculovirus expression system in a continuous insect cell line that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda. This vaccine complies with the World Health Organization (WHO) recommendation (Northern Hemisphere) and EU recommendation for the 2023/2024 season. Supemtek may contain traces of octylphenol ethoxylate (see section 4.3). Excipients with known effect This medicine contains 0.0275 mg of polysorbate 20 (E432) in each 0.5 mL dose (see section 4.4). For the full list of excipients, see section 6.1. | Solution for injection in pre-filled syringe (injection). Clear and colourless solution. | Aventis Pharma Limited 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK Trading as: Sanofi Pasteur 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK | PLGB 04425/0879 | July 28, 2025 | July 28, 2025 | See Details |
| 172 | MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY | One dose (0.5 mL) contains: Neisseria meningitidis group A polysaccharide1 10 micrograms Neisseria meningitidis group C polysaccharide1 10 micrograms Neisseria meningitidis group W polysaccharide1 10 micrograms Neisseria meningitidis group Y polysaccharide1 10 micrograms 1Conjugated to tetanus toxoid carrier protein 55 micrograms For the full list of excipients, see section 6.1. | Solution for injection Clear colourless solution. | Aventis Pharma Limited 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK Trading as: Sanofi 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK | PLGB 04425/0878 | June 26, 2025 | Jan. 15, 2026 | See Details |
| 171 | Nevirapine Teva 200 mg tablets | Each tablet contains 200 mg of nevirapine (as anhydrous). Excipient with known effect: Each tablet contains 168 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. | Tablet White, oval, biconvex tablets. One side is debossed with "N", a scoreline and "200". The opposite side is debossed with a scoreline. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. | Teva UK Limited Ridings Point, Whistler Drive Castleford, WF10 5HX United Kingdom | PLGB 00289/2506 | Jan. 1, 2021 | Jan. 1, 2021 | See Details |
| 170 | AJOVY 225 mg solution for injection in pre-filled pen | One pre-filled pen contains 225 mg fremanezumab. Fremanezumab is a humanised monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection (injection) Clear to opalescent, colourless to slightly yellow solution with a pH of 5.5 and an osmolality of 300-450 mOsm/kg. | Teva UK Limited Ridings Point Whistler Drive Castleford WF10 5HX United Kingdom | PLGB 00289/2504 | Jan. 1, 2021 | April 17, 2024 | See Details |
| 169 | AJOVY 225 mg solution for injection in pre-filled syringe | One pre-filled pen contains 225 mg fremanezumab. Fremanezumab is a humanised monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. | Solution for injection (injection) Clear to opalescent, colourless to slightly yellow solution with a pH of 5.5 and an osmolality of 300-450 mOsm/kg. | Teva UK Limited Ridings Point Whistler Drive Castleford WF10 5HX United Kingdom | PLGB 00289/2461 | Jan. 1, 2021 | April 17, 2024 | See Details |
| 168 | MabThera 1400 mg solution for subcutaneous injection | Each mL contains 120 mg of rituximab. Each vial contains 1400 mg/11.7 mL rituximab. Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences. The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures. For the full list of excipients, see section 6.1. | Solution for injection. Clear to opalescent, colourless to yellowish liquid with pH of 5.2 – 5.8 and osmolality of 300 - 400 mOsmol/kg. | Roche Products Limited 6 Falcon Way, Shire Park Welwyn Garden City AL7 1TW United Kingdom 33 mabthera0001m1-3-1-uk-spc-clean-PLGB00031-0866 | PLGB 00031/0866 | Jan. 1, 2021 | Aug. 15, 2024 | See Details |
| 167 | MabThera 500 mg concentrate for solution for infusion | MabThera 500 mg concentrate for solution for infusion Each mL contains 10 mg of rituximab. Each 50 mL vial contains 500 mg of rituximab. Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences. The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures. Excipients with known effect Each 50 mL vial contains 11.5 mmol (263.2 mg) sodium. For the full list of excipients, see section 6.1. | Concentrate for solution for infusion. Clear, colourless liquid with pH of 6.2 – 6.8 and osmolality of 324 - 396 mOsmol/kg. | Roche Products Limited 6 Falcon Way, Shire Park 64 Mabthera-0001-m1-3-1-uk-spc-clean- PLGB00031-0864-0865 Welwyn Garden City AL7 1TW United Kingdom | PLGB 00031/0865 | Jan. 1, 2021 | July 3, 2024 | See Details |
| 166 | MabThera 100 mg concentrate for solution for infusion | MabThera 100 mg concentrate for solution for infusion Each mL contains 10 mg of rituximab. Each 10 mL vial contains 100 mg of rituximab. Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences. The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures. Excipients with known effect Each 10 mL vial contains 2.3 mmol (52.6 mg) sodium. For the full list of excipients, see section 6.1. | Concentrate for solution for infusion. Clear, colourless liquid with pH of 6.2 – 6.8 and osmolality of 324 - 396 mOsmol/kg. | Roche Products Limited 64 Mabthera-0001-m1-3-1-uk-spc-clean- PLGB00031-0864-0865 6 Falcon Way, Shire Park Welwyn Garden City AL7 1TW United Kingdom | PLGB 00031/0864 | Jan. 1, 2021 | July 3, 2024 | See Details |