Octagam 50 mg/ml otopina za infuziju
| Name | Octagam 50 mg/ml otopina za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-315670569 |
| Active Substance | imunoglobulin normalni, ljudski, intravenski |
| Composition | jedan ml otopine za infuziju sadrži 50 mg imunoglobulina normalnog, ljudskog, što odgovara ukupnom sadržaju proteina od čega je najmanje 95% ljudski imunoglobulin G |
| Pharmaceutical Form | otopina za infuziju |
| Manufacturer | Octapharma Pharmazeutika Produktionsges.m.b.H., Beč, Austrija Octapharma S.A.S., Lingolsheim, Francuska Octapharma AB, Stockholm, Švedska |
| Marketing Authorisation Holder | Jana Pharm d.o.o., Lopašićeva 6, Zagreb, Hrvatska |
| Marketing Authorisation Date | 17.05.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/22-02/194 |
| Registration Number | 381-12-01/70-23-06 |
| 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 | J06BA02 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
