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 | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | J06BA02 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |