This brand name is authorized in Nigeria.
The drug MITIDE contains one active pharmaceutical ingredient (API):
1
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UNII
A0Z3NAU9DP - BICALUTAMIDE
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Bicalutamide is a non-steroidal antiandrogen, devoid of other endocrine activity. It binds to androgen receptors without activating gene expression, and thus inhibits the androgen stimulus. Regression of prostatic tumours results from this inhibition. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| B4-3936 | Tablet | Mitide Tablets_ TAB 50 mg 1 x 30's (in blisters or HDPE bottle) | Film-coated Tablets. Yellow coloured, round-shaped biconvex tablet, both sides plain. MITIDE TABLETS BICALUTAMIDE TABLETS USP 50MG BICALUTAMIDE USP 50MG Q.S. B4-3936 Drugs Imported Products 1X30 Prescription Only Medicine (POM) 03/12/2023 MANOLA PHARMACEUTICALS LTD, BLOCK 89A, OBA KAYODE AKNYEMI WAY, AMUWO ODOFIN LAGOS LAGOS LAGOS 8103078742 regulatorymanola@gmail.com NAPROD LIFE SCIENCES PVT. LTD, G-17/1, M.I.D.C., BOISAR THANE, INDIA, India | 28/08/2024 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| L02BB03 | Bicalutamide | L Antineoplastic and immunomodulating agents → L02 Endocrine therapy → L02B Hormone antagonists and related agents → L02BB Anti-androgens |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| NG | Registered Drug Product Database | B4-3936 |
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