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Hazard - P - B - T - Risk Exempt

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.

Author: Health and Medical Care Administration, Region Stockholm