Prophylaxis of influenza disease in adults and children from 6 months of age. Influenza vaccine TIV Viatris should be used in accordance with official recommendations.

Posology Adults: 0.5 ml. Paediatric population Children from 6 months to 17 years of age: 0.5 ml. Children less than 9 years of age, who have not previously been vaccinated with a seasonal influenza vaccine: a second dose of 0.5 ml should be given after an interval of at least 4 weeks. Infants less than 6 months of age: the safety and efficacy of Influenza vaccine TIV Viatris have not been established. No data are available. Method of Administration Immunisation should be carried out by intramuscular or deep subcutaneous injection. The preferred sites for intramuscular injection are the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 6 months through 35 months of age, or the deltoid muscle in children from 36 months of age and adults. Precautions to be taken before handling or administering the medicinal product: see section 6.6 For instructions for preparation of the medicinal product before administration, see section 6.6.

Hypersensitivity to the active substances, to any of the excipients listed in section 6.1 or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin. Immunisation shall be postponed in patients with febrile illness or acute infection.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. Influenza vaccine TIV Viatris should under no circumstances be administered intravascularly. As with other vaccines administered intramuscularly, Influenza vaccine TIV Viatris should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions can occur following, or even before, any vaccination as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints. Influenza vaccine TIV Viatris is not effective against all possible strains of influenza virus. Influenza vaccine TIV Viatris is intended to provide protection against those strains of virus from which the vaccine is prepared and to closely related strains. As with any vaccine, a protective immune response may not be elicited in all vaccinees. Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. Interference with serological testing: see section 4.5. Sodium and potassium content This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’. This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially “potassium- free”.

No

Pregnancy Inactivated influenza vaccines can be used in all stages of pregnancy. Larger datasets on safety are available for the second and third trimester, compared with the first trimester; however, data from worldwide use of influenza vaccine do not indicate any adverse fetal and maternal outcomes attributable to the vaccine. Breast-feeding Influenza vaccine TIV Viatris may be used during breast-feeding. Fertility No fertility data are available.

Influenza vaccine TIV Viatris has no or negligible influence on the ability to drive and use machines.

a. Summary of safety profile Data for Influvac sub-unit Tetra are relevant to Influenza vaccine TIV Viatris sub-unit TIV because both vaccines are manufactured using the same process. The safety of Influenza vaccine TIV Viatris was evaluated in several clinical trials and similar rates of solicited adverse reactions were observed in recipients of quadrivalent or trivalent formulations. Most reactions usually occurred within the first 3 days following vaccination and resolved spontaneously within 1 to 3 days after onset. The intensity of these reactions was generally mild. In all age groups, the most frequently reported local adverse reaction was vaccination site pain. The most frequently reported systemic adverse reactions in adults and children from 6 to 17 years of age were fatigue and headache, and for children from 3 to 5 years of age drowsiness, irritability and loss of appetite. The most frequently reported systemic adverse reactions in children from 6 months to 35 months of age were irritability/fussiness. In rare cases, allergic reactions may evolve to shock, angioedema (see section 4.4). b. Tabulated summary of adverse reactions The following have been observed during clinical trials with Influvac sub-unit Tetra or are resulting from post-marketing experience with Influenza vaccine TIV Viatris sub-unit TIV and Influvac sub-unit Tetra with the following frequencies: very common (=1/10); common (=1/100, <1/10); uncommon (=1/1,000, <1/100); and not known (adverse reactions from post-marketing experience; cannot be estimated from the available data). Adults (including elderly) MedDRA System Organ Class Very common = 1/10 Common = 1/100 to < 1/10 Uncommon = 1/1,000 to < 1/100 Not Knowna (cannot be estimated from the available data) Blood and lymphatic system Transient thrombocytopenia, transient MedDRA System Organ Class Very common = 1/10 Common = 1/100 to < 1/10 Uncommon = 1/1,000 to < 1/100 Not Knowna (cannot be estimated from the available data) lymphadenopathy Immune system disorders Allergic reactions, in rare cases leading to shock, angioedema Nervous system disorders Headacheb Neuralgia, paraesthesia, febrile convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome Vascular disorders Vasculitis associated in very rare cases with transient renal involvement Skin and subcutaneous tissue disorders Sweating Generalised skin reactions including pruritus, urticaria or non-specific rash Musculoskeletal and connective tissue disorders Myalgia, arthralgia General disorders and administration site conditions Fatigue Local reaction: pain Malaise, shivering Local reactions: redness, swelling, ecchymosis, induration Fever a Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure b In elderly adults (= 61 years) reported as common Paediatric population (6 months to 17 years of age) MedDRA System Organ Class Very common = 1/10 Common = 1/100 to < 1/10 Uncommon = 1/1,000 to < 1/100 Not Knowna (cannot be estimated from the available data) Blood and lymphatic system Transient thrombocytopenia, transient lymphadenopathy Immune system disorders Allergic reactions, in rare cases leading to shock, angioedema MedDRA System Organ Class Very common = 1/10 Common = 1/100 to < 1/10 Uncommon = 1/1,000 to < 1/100 Not Knowna (cannot be estimated from the available data) Nervous system disorders Headachec, Drowsinessb Neuralgia, paraesthesia, febrile convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome Vascular disorders Vasculitis associated in very rare cases with transient renal involvement Skin and subcutaneous tissue disorders Sweatingf Generalised skin reactions including pruritus, urticaria or non-specific rash Metabolism and nutrition disorders Appetite lossb Gastrointestinal disorders Nauseac, abdominal painc, diarrhoeae, vomitinge Psychiatric disorders Irritability/fussinessb Musculoskeletal and connective tissue disorders Myalgiac Arthralgiac General disorders and administration site conditions Fatiguec, feverf, malaisec Local reactions: pain, redness, swellingd, indurationd Shiveringc Local reaction: ecchymosis a Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure b Reported in children 6 months to 5 years of age c Reported in children 6 to 17 years of age d Reported as common in children 6 to 35 months of age e Reported as common in children 3 to 5 years of age f Reported as common in children 3 to 17 years of age Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Overdosage is unlikely to have any untoward effect

Pharmacotherapeutic group: Influenza vaccine, ATC Code: J07BB02. Mechanism of action Influenza vaccine TIV Viatris provides active immunisation against three influenza virus strains: an A/(H1N1) strain, an A/(H3N2) strain, and a B strain. It induces humoral antibodies against the haemagglutinins. These antibodies neutralise influenza viruses. Specific levels of haemagglutination-inhibition (HI) antibody titre post-vaccination with inactivated influenza virus vaccines have not been correlated with protection from influenza illness but the HI antibody titres have been used as a measure of vaccine activity. An immune response is generally obtained within 2 to 3 weeks. The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months. Pharmacodynamic effects Data for Influvac sub-unit Tetra are relevant to Influenza vaccine TIV Viatris because both vaccines are manufactured using the same process. Efficacy and immunogenicity of Influenza vaccine TIV Viatris in children 6 - 35 months of age The efficacy of Influvac sub-unit Tetra was evaluated in a randomised, observer blind, non-influenza vaccine-controlled study (INFQ3003) conducted during 3 influenza seasons 2017 to 2019 in Europe and Asia. Healthy subjects aged 6 - 35 months received two doses of Influvac sub-unit Tetra (N=1005) or non-influenza control vaccine (N=995) approximately 28 days apart. Vaccine efficacy was assessed for the prevention of reverse transcription polymerase chain reaction (RT-PCR) -confirmed influenza A and/or B disease due to any influenza strain. All RT-PCR-positive specimens were further tested for viability in cell culture and to determine whether the circulating viral strains matched those in the vaccine. Table: Efficacy in children 6 – 35 months of age Influvac sub-unit Tetra N=1005 Non-influenza control-vaccine N=995 Vaccine efficacy (95% CI) Laboratory-confirmed influenza caused by: n n - Any influenza A or B strain 59 117 0.54 (0.37 - 0.66) - Culture confirmed vaccine matching strains 19 56 0.68 (0.45 - 0.81) Vaccine efficacy: proportion of influenza cases prevented by the vaccination N=number of subjects vaccinated n=number of influenza cases CI=confidence interval Table: Seroconversion rates in children 6 – 35 months of age Influenza season NH 2017-20181 N=348 Influenza season NH 2018-20191 N=359 Influenza season SH 20191 N=225 Seroconversion Rates (95% confidence interval) A/H1N1 74.4% (69.5%, 78.9%) 76.0% (71.3%, 80.4%) 69.8% (63.3%, 75.7%) A/H3N2 92.5% (89.2%, 95.0%) 86.6% (82.7%, 90.0%) 86.2% (81.0%, 90.4%) B (Yamagata) 35.5% (30.4%, 40.8%) 56.0% (50.7%, 61.2%) 16.9% (12.2%, 22.4%) B (Victoria) 26.5% (21.9%, 31.5%) 65.2% (60.0%, 70.1%) 47.6% (40.9%, 54.3%) N= number of subjects included in immunogenicity analysis 1containing recommended strains by WHO for respective season for quadrivalent vaccines Immunogenicity of Influenza vaccine TIV Viatris in children 3 – 17 years of age and adults (including elderly) Clinical studies performed in adults (INFQ3001) and children of 3 to 17 years of age (INFQ3002) assessed the immunogenicity of Influvac sub-unit Tetra and its non-inferiority to trivalent Influenza vaccine TIV Viatris formulations for the postvaccination HI Geometric mean antibody titres (GMT) and seroconversion rates. Children received one or two doses of vaccine based on their influenza vaccine history. Table: Post-vaccination GMTs and seroconversion rates in adults Adults 18 – 60 years of age Influvac sub-unit Tetra N=768 Influenza vaccine TIV Viatris 1 N=112 Influenza vaccine TIV Viatris 2 N=110 GMT (95% confidence interval) A/H1N1 272.2 (248.0, 298.8) 304.4 (235.1, 394.1) 316.0 (245.1, 407.3) A/H3N2 442.4 (407.6, 480.2) 536.5 (421.7, 682.6) 417.0 (323.7, 537.1) B (Yamagata)3 162.5 (147.8, 178.7) 128.7 (100.3, 165.2) 81.7 (60.7, 109.9) B (Victoria)4 214.0 (195.5, 234.3) 85.1 (62.6, 115.6) 184.7 (139.0, 245.3) Seroconversion rate (95% confidence interval) A/H1N1 59.4% (55.8%, 62.9%) 65.5% (55.8%, 74.3%) 64.8% (55.0%, 73.8%) A/H3N2 51.3% (47.7%, 54.9%) 61.6% (51.9%, 70.6%) 55.5% (45.7%, 64.9%) B (Yamagata)3 59.2% (55.7%, 62.8%) 58.7% (48.9%, 68.1%) 40.9% (31.6%, 50.7%) B (Victoria)4 70.2% (66.8%, 73.4%) 51.4% (41.6%, 61.1%) 66.4% (56.7%, 75.1%) Elderly 61 years of age and older Influvac sub-unit Tetra N=765 Influenza vaccine TIV Viatris 1 N=108 Influenza vaccine TIV Viatris 2 N=110 GMT (95% confidence interval) A/H1N1 127.2 (114.9, 140.9) 142.4 (107.6, 188.3) 174.2 (135.9, 223.3) A/H3N2 348.5 (316.8, 383.5) 361.5 (278.3, 469.6) 353.4 (280.7, 445.0) B (Yamagata)3 63.7 (57.7, 70.4) 57.4 (43.6, 75.7) 27.3 (20.7, 36.0) B (Victoria)4 109.4 (98.1, 122.0) 48.0 (34.6, 66.6) 106.6 (79.7, 142.8) Seroconversion rate (95% confidence interval) A/H1N1 50.3% (46.7%, 54.0%) 56.6% (46.6%, 66.2%) 58.2% (48.4%, 67.5%) A/H3N2 39.3% (35.8%, 42.9%) 44.4% (34.9%, 54.3%) 43.6% (34.2%, 53.4%) B (Yamagata)3 49.9% (46.2%, 53.5%) 46.2% (36.5%, 56.2%) 30.0% (21.6%, 39.5%) B (Victoria)4 53.6% (50.0%, 57.2%) 25.0% (17.2%, 34.3%) 55.6% (45.7%, 65.1%) N= number of subjects included in immunogenicity analysis 1containing A/H1N1, A/H3N2 and B (Yamagata lineage) 2containing A/H1N1, A/H3N2 and B (Victoria lineage) 3recommended B strain by WHO for the season 2014-2015 NH for trivalent vaccines 4additional recommended B strain by WHO for season 2014-2015 NH for quadrivalent vaccines Table: Seroconversion rates in children 3 – 17 years of age Children 3 - 17 years of age Influvac sub-unit Tetra N=396 Influenza vaccine TIV Viatris 1 N=389 Influenza vaccine TIV Viatris 2 N=399 Seroconversion rate (95% confidence interval) A/H1N1 60.1% (55.1% , 65.0%) 61.8% (56.7%, 66.6%) 59.1% (54.1%, 64.0%) A/H3N2 80.6% (76.3% , 84.3%) 82.4% (78.3%, 86.1%) 80.7% (76.5%, 84.5%) B (Yamagata)3 79.3% (75.0% , 83.2%) 73.1% (68.4%, 77.5%) 28.1% (23.7%, 32.8%) B (Victoria)4 76.5% (72.0% , 80.6%) 39.5% (34.6%, 44.6%) 72.7% (68.0%, 77.0%) N= number of subjects included in immunogenicity analysis 1containing A/H1N1, A/H3N2 and B (Yamagata lineage) 2containing A/H1N1, A/H3N2 and B (Victoria lineage) 3recommended B strain by WHO for the season 2016-2017 NH for trivalent vaccines 4additional recommended B strain by WHO for season 2016-2017 NH for quadrivalent vaccines

Not applicable.

Non-clinical data revealed no special hazard for humans based on conventional studies of repeat dose and local toxicity, reproductive and developmental toxicity and safety pharmacology studies.

Potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate and water for injections.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

1 year.

Store in a refrigerator (2°C - 8°C). Do not freeze. Store in the original package in order to protect from light.

0.5 ml suspension for injection in prefilled syringe with or without needle (glass, type I), pack of 1 or 10. Not all pack sizes may be marketed.

The vaccine should be allowed to reach room temperature before use. Shake before use. Inspect visually prior to administration. Any unused product or waste material should be disposed of in accordance with local requirements.

Feb. 5, 2026

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