Gemcitabin Accord 100 mg/ml koncentrat za otopinu za infuziju
Name | Gemcitabin Accord 100 mg/ml koncentrat za otopinu za infuziju |
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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 | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L01BC05 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |