Octanine F 100 IU/ml prašak i otapalo za otopinu za injekciju
Name | Octanine F 100 IU/ml prašak i otapalo za otopinu za injekciju |
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Marketing Authorisation Number | HR-H-479880748 |
Active Substance | koagulacijski faktor IX, ljudski |
Composition | lijek sadrži oko 100 IU/ml ljudskog koagulacijskog faktora IX |
Pharmaceutical Form | prašak i otapalo za otopinu za injekciju |
Manufacturer | Octapharma Pharmazeutika Produktionsges.m.b.H., Beč, Austrija Octapharma S.A.S., Lingolsheim, Francuska |
Marketing Authorisation Holder | Jana Pharm d.o.o., Lopašićeva 6, Zagreb, Hrvatska |
Marketing Authorisation Date | 28.06.2017 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/16-02/178 |
Registration Number | 381-12-01/70-17-06 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | B02BD04 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |