Rituximab

Assessment report

Det finns utredningsrapporter för flera läkemedel. Assessment report för MabThera (rituximab) 31 Januari 2019, EMA/206826/2019, är den senaste (sökning EMAs webbplats 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 miljöinformation

Fass miljöinformation för Mabthera från Roche (hämtad 2019-08-21).

Användning av aminosyror, proteiner och peptider bedöms inte medföra någon miljöpåverkan.

Detaljerad 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.