This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, UK.
The drug ABRAXANE contains one active pharmaceutical ingredient (API):
1
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UNII
P88XT4IS4D - PACLITAXEL
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Paclitaxel is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilises microtubules by preventing depolymerisation. This stability results in the inhibition of the normal dynamic reorganisation of the microtubule network that is essential for vital interphase and mitotic cellular functions. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| ABRAXANE Powder for suspension for infusion | 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 | |
|---|---|---|
| L01CD01 | Paclitaxel | 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) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 10150F, 10165B, 4531L, 7270P |
| BR | Câmara de Regulação do Mercado de Medicamentos | 562417080000007 |
| CA | Health Products and Food Branch | 02281066 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 299-MEE-0514 |
| EE | Ravimiamet | 1342998, 1636309 |
| ES | Centro de información online de medicamentos de la AEMPS | 07428001 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 397641 |
| FR | Base de données publique des médicaments | 68739019 |
| GB | Medicines & Healthcare Products Regulatory Agency | 201590 |
| HK | Department of Health Drug Office | 62459 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 7936 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1032063, 1072784 |
| NL | Z-Index G-Standaard | 15690172 |
| NL | Z-Index G-Standaard, PRK | 98957 |
| NZ | Medicines and Medical Devices Safety Authority | 14039 |
| PL | Rejestru Produktów Leczniczych | 100265356 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W69520001 |
| SG | Health Sciences Authority | 14532P |
| US | FDA, National Drug Code | 68817-134 |
| ZA | Health Products Regulatory Authority | 50/26/0182 |
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