Remurel 40 mg/ml otopina za injekciju u napunjenoj štrcaljki
| Name | Remurel 40 mg/ml otopina za injekciju u napunjenoj štrcaljki |
|---|---|
| Marketing Authorisation Number | HR-H-589516554 |
| Active Substance | glatirameracetat |
| Composition | jedna napunjena štrcaljka (1 ml) sadrži 40 mg glatirameracetata, što odgovara 36 mg glatiramera |
| 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 | 23.05.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/21-02/231 |
| Registration Number | 381-12-01/70-23-07 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L03AX13 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| 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. |
