This brand name is authorized in Austria, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Spain, UK.
The drug EVOLTRA contains one active pharmaceutical ingredient (API):
1
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UNII
762RDY0Y2H - CLOFARABINE
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Clofarabine is a purine nucleoside anti-metabolite. Its antitumour activity is believed to be due to 3 mechanisms. Clofarabine produces DNA polymerase inhibition resulting in termination of DNA chain elongation and/or DNA synthesis/repair and ribonucleotide reductase inhibition with reduction of cellular deoxynucleotide triphosphate (dNTP) pools. Clofarabine also produces disruption of mitochondrial membrane integrity with the release of cytochrome C and other proapoptotic factors leading to programmed cell death even in non-dividing lymphocytes. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| EVOLTRA Concentrate for solution for infusion | MPI, EU: SmPC | European Medicines Agency (EU) | |
| Evoltra 1mg/ml 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 | |
|---|---|---|
| L01BB06 | Clofarabine | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01B Antimetabolites → L01BB Purine analogues |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| EE | Ravimiamet | 1249893, 1249905, 1249916, 1249927, 1458390 |
| ES | Centro de información online de medicamentos de la AEMPS | 06334005 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 048494 |
| FR | Base de données publique des médicaments | 65270506 |
| GB | Medicines & Healthcare Products Regulatory Agency | 340018 |
| HK | Department of Health Drug Office | 61183 |
| JP | 医薬品医療機器総合機構 | 4229403A1022 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1028052, 1028053, 1028054, 1028055, 1054544 |
| NL | Z-Index G-Standaard, PRK | 85987 |
| PL | Rejestru Produktów Leczniczych | 100184652 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W53291001, W53291002, W53291003, W53291004, W53291005 |
| SG | Health Sciences Authority | 14026P |
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