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.
This medicinal substance has been classified in the anatomical therapeutic chemical (ATC) classification according to its main therapeutic use as follows:
| ATC code | Group title | Classification |
|---|---|---|
| V03AB37 | V Various → V03 All other therapeutic products → V03A All other therapeutic products → V03AB Antidotes | |
Competent medicine agencies globally have authorized commercialization of this active ingredient according to these medication package inserts (MPIs):
| Title | Information Source | Document Type | |
|---|---|---|---|
| PRAXBIND Solution for injection | European Medicines Agency (EU) | MPI, EU: SmPC |
Idarucizumab is an active ingredient of these brands:
United States (US)Austria (AT)Brazil (BR)Canada (CA)Croatia (HR)Cyprus (CY)Ecuador (EC)Estonia (EE)Finland (FI)France (FR)Hong Kong (HK)Ireland (IE)Italy (IT)Japan (JP)Lithuania (LT)Netherlands (NL)New Zealand (NZ)Poland (PL)Romania (RO)Singapore (SG)South Africa (ZA)Spain (ES)Turkey (TR)United Kingdom (UK)Note the following: The list of brand names is continuously updated, and thus does not include the total of products circulating worldwide. |
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