Zolgensma
The medicinal product has been authorised by the European Commission (EC) via centralised procedure in all EU Member States, based on the European Medicines Agency (EMA) experts' opinion.
| Name | Zolgensma |
|---|---|
| Active Substance | onasemnogen abeparvovek |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| ATC Code | M09AX09 |
| Medicinal product marketed in the Croatia | Da |
| Summary of product characteristics (SmPC), labelling and package leaflet (PL) | download |
| Link to the European Medicines Agency's (EMA) product information | download |
| Link to the European Commission's (EC) decisions | download |
| Educational materials for healthcare professionals |
Vodič za zdravstvene radnike, verzija 1 |
| Educational materials for patients / caregivers |
Vodič za njegovatelje, verzija 2 |
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o prijavljenim fatalnim ishodima uslijed akutnog zatajenja jetre prilikom primjene lijeka Zolgensma (onasemnogen abeparvovek) prijavljenima izvan RH | 16.02.2023 | Novartis Hrvatska d.o.o. |
