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 |
|---|---|
| Former Name | Octanine F 500 IU prašak i otapalo za otopinu za injekciju; Octanine F 1000 IU prašak i otapalo za otopinu za injekciju |
| 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 | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | B02BD04 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
