Gemcitabin Accord 100 mg/ml koncentrat za otopinu za infuziju
| Name | Gemcitabin Accord 100 mg/ml koncentrat za otopinu za infuziju |
|---|---|
| Former Name | Gemcitabin PharmaS 100 mg/ml koncentrat za otopinu za infuziju |
| Marketing Authorisation Number | HR-H-420311969 |
| Active Substance | gemcitabinklorid |
| Composition | 1 ml koncentrata sadrži 100 mg gemcitabina u obliku gemcitabinklorida |
| Pharmaceutical Form | koncentrat za otopinu za infuziju |
| Manufacturer | PharmaS d.o.o., Zagreb, Hrvatska Accord Healthcare Polska Sp. z o.o., Pabianice, Poljska |
| Marketing Authorisation Holder | Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, Poljska |
| Marketing Authorisation Date | 12.11.2021 |
| MA Period of Validity | 21.06.2026 |
| Classification Number | UP/I-530-09/19-01/115 |
| Registration Number | 381-12-01/70-21-21 |
| 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 | L01BC05 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
