Idarucizumab
Information
Assessment report
Assessment report for Praxbind (idarucizumab), 24 September 2015, EMA/713107/2015.
"The Fab idarucizumab is a protein which is unlikely to result in significant risk to the environment. This was agreed by the CHMP."
Fass environmental information
Fass environmental information for Praxbind from Boehringer Ingelheim (downloaded 2019-09-04).
Risk
The use of amino acids, proteins and peptides is not expected to have any environmental impact.
Detailed information
According to the European Medicines Agency guideline on environmental risk assessments for pharmaceuticals (EMA/CHMP/SWP/4447/00),vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates, lipids proteins, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment.
References
- European Medicines Agency. European public assessment reports (EPAR). Praxbind (idarucizumab), 24 September 2015, EMA/713107/2015.
- Fass för vårdpersonal.
- European Medicines Agency, EMA: Committee for Medicinal Products for Human Use (CHMP). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. 1 June 2006.
Author: The Pharmaceutical unit of Region Stockholm