Panzyga 100 mg/ml otopina za infuziju
Name | Panzyga 100 mg/ml otopina za infuziju |
---|---|
Marketing Authorisation Number | HR-H-514282065 |
Active Substance | imunoglobulin normalni, ljudski, intravenski |
Composition | 1 ml otopine za infuziju sadrži 100 mg imunoglobulina normalnog, ljudskog (čistoća od najmanje 95 % IgG) |
Pharmaceutical Form | otopina za infuziju |
Manufacturer | Octapharma S.A.S., Lingolsheim, Francuska Octapharma Pharmazeutika Produktionsges.m.b.H., Beč, Austrija |
Marketing Authorisation Holder | Octapharma (IP) SPRL, Allee De La Recherche 65, Anderlecht, Belgija |
Marketing Authorisation Date | 15.10.2020 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/20-02/63 |
Registration Number | 381-12-01/38-20-03 |
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 | Ne |
SmPC | download |
PL | download |
Public Assessment Report | download |