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, Route de Lennik 451, 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 | 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 | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |