| Code | 4615D | ||||||||||
| MA number | EU/1/20/1443/036 | ||||||||||
| Product Form: | sol inf 1x5,5 ml+13x8,3 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: |
|
||||||||||
| 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_Príručka pre zdravotníckych pracovníkov.pdf
|
| Dokument: |
Zolgensma_Príručka pre rodičov a opatrovatelov.pdf
|
| Safety feature | Yes |
| Data update: | 07.03.2023 |
