Detailed SMPC and OD register data for: Pombiliti 105 mg powder for concentrate for solution for infusion
Data as extracted from Orphan Designation Register
Product (OD)
Pombiliti 105 mg powder for concentrate for solution for infusion
PL number (OD)
PLGB 25823/0003
OD Designation ID (OD)
OD1
Active substance (OD)
CIPAGLUCOSIDASE ALFA
Data as extracted from SMPC. (PS: More information at bottom of the page)
Product (SMPC)
PL Number (SMPC)
Composition/ Active Substance (SMPC)
Dose form (SMPC)
Marketing Authorisation holder details (SMPC)
AI match to EMA Substance Dictionary
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SMPC composition / active substance
Matched EMA substance
EMA SMS ID
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Further information for:
Select a section below to read the detailed content extracted from the SMPC / Orphan Designation register.
OD Indication (OD)
Authorised orphan indication: Long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset Pompe disease (acid ?-glucosidase [GAA] deficiency
Full Designation Number(OD)
PLGB 25823/0003/OD1
Orphan Condition(OD)
Glycogen storage disease type II (Pompe’s disease)
All Indications (SMPC)
All Contraindications (SMPC)
Warnings/Precautions (SMPC)
Interactions (SMPC)
Pregnancy/Lactation (SMPC)
Driving/Machines (SMPC)
Undesirable effects (SMPC)
Overdose (SMPC)
Shelf life (SMPC)
Storage (SMPC)
Container description (SMPC)
Handling/Disposal (SMPC)
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