This brand name is authorized in Nigeria. It is also authorized in Austria, Brazil, Cyprus, Ecuador, Estonia, France, Hong Kong SAR China, Ireland, Japan, Lithuania, Mexico, Netherlands, Poland, Spain, Tunisia, United States.
The drug TAXOTERE contains one active pharmaceutical ingredient (API):
1
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UNII
15H5577CQD - DOCETAXEL
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Docetaxel is an antineoplastic agent which acts by promoting the assembly of tubulin into stable microtubules and inhibits their disassembly which leads to a marked decrease of free tubulin. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| B4-4447 | Concentrate for solution for infusion | Taxotere 20 mg Concentrate for Solution for Infusion INJ_SOL_CONC 20 mg/mL | Concentrate for Solution for Infusion Each mL of concentrate contains: Docetaxel (as Trihydrate) 20 mg One vial of 1 mL of concentrate contains: Docetaxel 20 mg Excipients with known effect: Each vial of 1 mL of concentrate contains: Ethanol anhydrous 0.5 mL (395 mg) | 26/08/2021 |
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| Taxotere 20mg/1ml concentrate for solution for infusion | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| L01CD02 | Docetaxel | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01C Plant alkaloids and other natural products → L01CD Taxanes |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| BR | Câmara de Regulação do Mercado de Medicamentos | 502812603158319, 502812604154317, 576720080084017, 576720080084117 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | H3020113, H3030113 |
| EE | Ravimiamet | 1028809, 1118843, 1455825, 1455836, 1476952 |
| ES | Centro de información online de medicamentos de la AEMPS | 95002003, 95002004, 95002005 |
| FR | Base de données publique des médicaments | 60385433, 60509781, 68257752 |
| HK | Department of Health Drug Office | 41353, 41354 |
| JP | 医薬品医療機器総合機構 | 4240405A1037, 4240405A2033 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1003176, 1003177, 1005304, 1005305, 1005573, 1005574, 1064326 |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 533M94 |
| NG | Registered Drug Product Database | B4-4447 |
| NL | Z-Index G-Standaard | 13998269, 14899418 |
| NL | Z-Index G-Standaard, PRK | 92851, 92878 |
| PL | Rejestru Produktów Leczniczych | 100065841, 100205615, 100217860, 100332822, 100332839 |
| SG | Health Sciences Authority | 14106P, 14107P |
| TN | Direction de la Pharmacie et du Médicament | 8903013H, 8903014H |
| US | FDA, National Drug Code | 0075-8004 |
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