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PRODUCT DETAIL

Zolgensma

Code 4614D
MA number EU/1/20/1443/035
Product Form: sol inf 2x5,5 ml+12x8,3 ml (liek.inj.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
MAH, country: Novartis Europharm Limited, Ireland
Therapeutic Class: 87 - VARIA I
ATC:
M MUSCULO-SKELETAL SYSTEM
M09 OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL
M09A OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL
M09AX Other drugs for disorders of the musculo-skeletal
M09AX09 Onasemnogene abeparvovec
Shelf life: 24
Container: vial
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 18.05.2020
Validity: 17.05.2027
SmPC + PL: European Medicines Agency's database
Dokument: Zolgensma_Prirucka pe rodicov a opatrovatelov.pdf  
Dokument: Zolgensma_Prirucka pre zdravotnickych pracovnikov.pdf  
Safety feature Yes
Data update: 07.03.2023
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