Code | 4584D | ||||||||||
MA number | EU/1/20/1443/005 | ||||||||||
Product Form: | sol inf 2x5,5 ml+2x8,3 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: |
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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 |