Tysabri
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 | Tysabri |
|---|---|
| Active Substance | natalizumab |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| ATC Code | L04AG03 |
| 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 |
Informacije za liječnike i smjernice za liječenje, verzija 8 Obrazac za nastavak liječenja Tysabrijem, verzija 5 Obrazac za početak liječenja Tysabrijem, verzija 5 Obrazac za trajni prekid liječenja Tysabrijem, verzija 3 Dodatne informacije za zdravstvene radnike, verzija 1 Kontrolna lista za izvanbolničku primjenu lijeka, verzija 1 |
| Educational materials for patients / caregivers |
Kartica s upozorenjem za bolesnika, verzija 5 |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o ažuriranju mjera minimizacije rizika od PML-a za Tysabri (natalizumab) | 16.03.2016 | Biogen Idec Limited |
