Remurel 40 mg/ml otopina za injekciju u napunjenoj štrcaljki
Name | Remurel 40 mg/ml otopina za injekciju u napunjenoj štrcaljki |
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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 | 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 |