Lemtrada
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 | Lemtrada |
|---|---|
| Active Substance | alemtuzumab |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| ATC Code | L04AG06 |
| 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 5 Kontrolni popis za liječnike, verzija 3 |
| Educational materials for patients / caregivers |
Vodič za bolesnike, verzija 5 Kartica za bolesnike, verzija 5 |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o ograničenju indikacije, dodatnim kontraindikacijama i mjerama minimizacije rizika za lijek Lemtrada (alemtuzumab) | 23.01.2020 | sanofi-aventis Croatia d.o.o. |
| Pismo zdravstvenim radnicima o ograničenju primjene lijeka Lemtrada zbog ozbiljnih nuspojava | 18.04.2019 | sanofi-aventis Croatia d.o.o. |
