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Hazard - P - B - T - Risk Exempt

Assessment report

There are assessment reports for several pharmaceuticals. Assessment report for MabThera (rituximab) 31 January 2019, EMA/206826/2019, is the latest (search EMA's website 2019-08-21).

"The pharmacologically active substance in MabThera, Rituximab (CAS 174722–31–7), is a recombinant immunoglobulin-G monoclonal antibody with a molecular mass of approximately 145 kD. As an unaltered protein, Rituximab is predicted to be metabolised by regular proteinolysis in the patient and biodegraded in sewage treatment, as shown for other monoclonal antibodies. Thus, Rituximab is unlikely to result in a significant risk to the environment and therefore it is submitted that it does not need a formal ERA according to the EMA 2006 Guideline (corr. 2). This is acceptable to the CHMP."

Fass environmental information

Fass environmental information for Mabthera from Roche (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, 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