Evrysdi
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 | Evrysdi |
|---|---|
| Active Substance | risdiplam |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| ATC Code | M09AX10 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| 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 |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o izostavljenoj obveznoj napomeni u označivanju i sažetku opisa svojstava lijeka za lijek Evrysdi 0,75 mg/ml prašak za oralnu otopinu (risdiplam) | 21.08.2025 | Roche d.o.o. |
