This brand name is authorized in Nigeria. It is also authorized in Australia, Austria, Croatia, Estonia, Finland, France, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Spain, UK, United States.
The drug MEKTOVI contains one active pharmaceutical ingredient (API):
1
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UNII
181R97MR71 - BINIMETINIB
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Binimetinib is an ATP-uncompetitive, reversible inhibitor of the kinase activity of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2. MEK proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation. Binimetinib inhibits activation of MEK by BRAF and inhibits MEK kinase activity. |
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This drug has been approved in Nigeria as follows:
Identifier | Form | Presentation | Description | Approval |
---|---|---|---|---|
A4-100332 | Tablet | Mektovi 15 mg Tablets TAB 15 mg 7 x 12's (in PVC/PVDC/Alu blisters) | Film-coated tablet (tablet). Yellow to dark yellow, unscored biconvex, ovaloid film-coated tablets approximately 12 mm in length and 5 mm in width, with the “A” logo debossed on one side of the tablet and “15” on the other side | 26/01/2023 |
Below package inserts are available for further reading:
Document | Type | Information Source | |
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MEKTOVI Film-coated tablet | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC Group | Classification | |
---|---|---|
L01EE03 | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EE Mitogen-activated protein kinase (MEK) inhibitors | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
Country | Identification scheme | Identifier(s) |
---|---|---|
AU | Pharmaceutical Benefits Scheme | 11948W, 11961M |
EE | Ravimiamet | 1780286, 1804407, 1872019 |
ES | Centro de información online de medicamentos de la AEMPS | 1181315001 |
FI | Lääkealan turvallisuus- ja kehittämiskeskus | 175004 |
FR | Base de données publique des médicaments | 67712453 |
GB | Medicines & Healthcare Products Regulatory Agency | 362853, 392452 |
IE | Health Products Regulatory Authority | 88989 |
IL | מִשְׂרַד הַבְּרִיאוּת | 8865 |
IT | Agenzia del Farmaco | 047197013, 047197025 |
JP | 医薬品医療機器総合機構 | 4291058F1024 |
LT | Valstybinė vaistų kontrolės tarnyba | 1086239, 1087044 |
NG | Registered Drug Product Database | A4-100332 |
NL | Z-Index G-Standaard, PRK | 167223 |
PL | Rejestru Produktów Leczniczych | 100411243 |
RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W68714001 |
US | FDA, National Drug Code | 70255-010 |
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