Medicinal Products

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 Medicinal product subject to medical prescription
Type of prescription ograničeni recept
Distribution Supply through pharmacies (community)
ATC Code M09AX09
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
Educational materials
for healthcare professionals
Vodič za zdravstvene radnike, verzija 2
Educational materials
for patients / caregivers
Vodič za njegovatelje, verzija 3

Packaging

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.
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