This brand name is authorized in Nigeria. It is also authorized in Estonia, Lithuania.
The drug GEMBIN contains one active pharmaceutical ingredient (API):
1
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UNII
U347PV74IL - GEMCITABINE HYDROCHLORIDE
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Gemcitabine (dFdC), which is a pyrimidine antimetabolite, is metabolised intracellularly by nucleoside kinase to the active diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. The cytotoxic effect of gemcitabine is due to inhibition of DNA synthesis by two mechanisms of action by dFdCDP and dFdCTP. |
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This drug has been approved in Nigeria as follows:
Identifier | Form | Presentation | Description | Approval |
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B4-4538 | Powder for injection | Gembin 1000 Injection INJ_PWD 1 g 1 x 1's (in vial) | Lyophilized powder for solution for injection in vial. A white to off white lyophilized mass | 31/07/2024 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC Group | Classification | |
---|---|---|
L01BC05 | Gemcitabine | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01B Antimetabolites → L01BC Pyrimidine analogues |
This drug has been assigned below unique identifiers within the countries it is being marketed:
Country | Identification scheme | Identifier(s) |
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EE | Ravimiamet | 1393039, 1393040, 1393051 |
LT | Valstybinė vaistų kontrolės tarnyba | 1035261, 1035262, 1035263 |
NG | Registered Drug Product Database | B4-4538 |
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