Ranibizumab
Information
Assessment report
Assessment report for Lucentis (ranibizumab) 13 October 2016, EMA/757247/2016.
"In line with the Guideline on the environmental risk assessment of medicinal products for human use (CHMP/SWP/4447/00 corr 2), since ranibizumab is a protein and unlikely to result in a significant risk to the environment, there is no need for ERA studies."
Fass environmental information
Fass environmental information for Lucentis from Novartis (downloaded 2019-08-21).
The use of amino acids, proteins and peptides is not considered 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). Lucentis (ranibizumab) 13 October 2016, EMA/757247/2016.
- 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: Health and Medical Care Administration, Region Stockholm