Octanate 500 IU prašak i otapalo za otopinu za injekciju
| Name | Octanate 500 IU prašak i otapalo za otopinu za injekciju |
|---|---|
| Marketing Authorisation Number | HR-H-067222873 |
| Active Substance | koagulacijski faktor VIII, ljudski |
| Composition | svaka bočica nominalno sadrži 500 IU ljudskog koagulacijskog faktora VIII |
| Pharmaceutical Form | prašak i otapalo za otopinu za injekciju |
| Manufacturer | Octapharma Pharmazeutika Produktionsges.m.b.H., Beč, Austrija Octapharma, Lingolsheim, Francuska Octapharma AB, Stockholm, Švedska |
| Marketing Authorisation Holder | Jana Pharm d.o.o., Lopašićeva 6, Zagreb, Hrvatska |
| Marketing Authorisation Date | 22.05.2019 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/17-02/622 |
| Registration Number | 381-12-01/70-19-09 |
| 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 | B02BD02 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |