Remurel 20 mg/ml otopina za injekciju u napunjenoj štrcaljki
| Name | Remurel 20 mg/ml otopina za injekciju u napunjenoj štrcaljki |
|---|---|
| Former Name | Brabio 20 mg/ml otopina za injekciju u napunjenoj štrcaljki |
| Marketing Authorisation Number | HR-H-759520422 |
| Active Substance | glatirameracetat |
| Composition | jedan 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 | Synthon Hispania S.L., Barcelona, Španjolska
Synthon BV, Nijmegen, Nizozemska |
| Marketing Authorisation Holder | Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka |
| Marketing Authorisation Date | 06.04.2021 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/20-02/79 |
| Registration Number | 381-12-01/154-21-09 |
| 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 | Trajni prekid opskrbe |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
