This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.
The drug PRAXBIND contains one active pharmaceutical ingredient (API):
1
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UNII
97RWB5S1U6 - IDARUCIZUMAB
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Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with very high affinity, approximately 300-fold more potent than the binding affinity of dabigatran for thrombin. The idarucizumab-dabigatran complex is characterised by a rapid on-rate and extremely slow off-rate resulting in a very stable complex. Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises their anticoagulant effect. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| PRAXBIND Solution for injection | 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 | |
|---|---|---|
| V03AB37 | V Various → V03 All other therapeutic products → V03A All other therapeutic products → V03AB Antidotes | |
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 | 504517090020902 |
| CA | Health Products and Food Branch | 02454343 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 70-MBE-0816 |
| EE | Ravimiamet | 1705238 |
| ES | Centro de información online de medicamentos de la AEMPS | 1151056001 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 376496 |
| FR | Base de données publique des médicaments | 63555182 |
| GB | Medicines & Healthcare Products Regulatory Agency | 310658 |
| HK | Department of Health Drug Office | 64759 |
| IT | Agenzia del Farmaco | 044561013 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1079097 |
| NL | Z-Index G-Standaard | 16202600 |
| NL | Z-Index G-Standaard, PRK | 129380 |
| NZ | Medicines and Medical Devices Safety Authority | 17568 |
| PL | Rejestru Produktów Leczniczych | 100356870 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W62267001 |
| SG | Health Sciences Authority | 15083P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699693770011 |
| US | FDA, National Drug Code | 0597-0197 |
| ZA | Health Products Regulatory Authority | 50/30.1/0315 |
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