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Hazard - P - B - T - Risk Exempt

Assessment report

Assessment report for Simponi (golimumab) 13 December 2018, EMA/898638/2018.

Since golimumab is an antibody (i.e. a protein), the product is not expected to pose a risk to the environment when used according to the labelling. Therefore, it is considered acceptable that no formal ERA according to the EMA 2006 Guideline (corr. 2) is needed for golimumab.

Fass environmental information

Fass environmental information for Simponi from MSD (downloaded 2019-08-20).

The use of amino acids, proteins and peptides is not considered to have any environmental impact.

According to the European Medicines Agency guideline on environmental risk assessments for pharmaceuticals (EMA/CMP/SWP/4447/00), vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates, lipids, 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