Copaxone 20 mg/ml otopina za injekciju u napunjenoj štrcaljki
| Name | Copaxone 20 mg/ml otopina za injekciju u napunjenoj štrcaljki |
|---|---|
| Marketing Authorisation Number | HR-H-157986508 |
| Active Substance | glatirameracetat |
| Composition | 1 ml otopine za injekciju sadrži 20 mg glatirameracetata, što odgovara 18 mg glatiramer baze po napunjenoj štrcaljki |
| Pharmaceutical Form | otopina za injekciju u napunjenoj štrcaljki |
| Manufacturer | Teva Pharmaceutical Europe BV, Haarlem, Nizozemska Norton Healthcare Limited T/A Ivax Pharmaceuticals UK, Runcorn, Cheshire, Ujedinjeno Kraljevstvo Merckle GmbH, Ulm, Njemačka Actavis Group PTC ehf., Hafnarfjoerdur, Island |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 15.02.2018 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/17-02/725 |
| Registration Number | 381-12-01/38-18-03 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L03AX13 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o anafilaktičkim reakcijama koje mogu nastupiti mjesecima do godinama nakon početka primjene lijekova koji sadrže glatirameracetat | 20.08.2024 | Pliva Hrvatska d.o.o., Zentiva, k.s. |
