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Adalimumab

Hazard - P - B - T - Risk Exempt

Information

Assessment report

There are assessment reports for different medicinal products with adalimumab. The latest information is for Kromeya (adalimumab), 31 January 2019, EMA/214726/2019.

"According to the CHMP Guideline on the Environmental Risk Assessment (ERA) of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00 corr 2) for products containing vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates and lipids as active pharmaceutical ingredient(s), an ERA should be provided. This ERA may consist of a justification for not submitting specific ERA studies. According to Directive 2001/83/EC, applicants are required to submit an ERA also for applications under Art 10(4) similar biological applications. The active substance is a protein composed of natural amino acids, the use of which will not alter the concentration or distribution of the substance in the environment. Therefore, adalimumab is not expected to pose a risk to the environment."

Fass environmental information

Fass environmental information for Humira (adalimumab) from AbbVie (downloaded 2019-09-03).

Risk

The use of amino acids, proteins and peptides is not expected 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