Libmeldy
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 | Libmeldy |
|---|---|
| Active Substance | atidarsagen autotemcel (obogaćena populacija autolognih stanica CD34+ koja sadrži hematopoetske matične i progenitorne stanice transducirane ex vivo lentivirusnim vektorom koji kodira gen ljudske arilsulfataze A (ARSA)) |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| ATC Code | A16AB21 |
| 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 |
