PRAXBIND

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug PRAXBIND contains one active pharmaceutical ingredient (API):

1 Idarucizumab
UNII 97RWB5S1U6 - IDARUCIZUMAB

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.

Read about Idarucizumab

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
PRAXBIND Solution for injection European Medicines Agency (EU) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
V03AB37 V Various → V03 All other therapeutic products → V03A All other therapeutic products → V03AB Antidotes
Discover more medicines within V03AB37

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 504517090020902
Country: CA Health Products and Food Branch Identifier(s): 02454343
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 70-MBE-0816
Country: EE Ravimiamet Identifier(s): 1705238
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 1151056001
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 376496
Country: FR Base de données publique des médicaments Identifier(s): 63555182
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 310658
Country: HK Department of Health Drug Office Identifier(s): 64759
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1079097
Country: NL Z-Index G-Standaard Identifier(s): 16202600
Country: NL Z-Index G-Standaard, PRK Identifier(s): 129380
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 17568
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100356870
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W62267001
Country: SG Health Sciences Authority Identifier(s): 15083P
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699693770011
Country: US FDA, National Drug Code Identifier(s): 0597-0197
Country: ZA Health Products Regulatory Authority Identifier(s): 50/30.1/0315

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.