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Ustekinumab

Hazard - P - B - T - Risk Exempt

Information

This summary information comes from the assessment report and Fass.

Exempt.

Assessment report

Assessment report for Stelara (ustekinumab) 14 January 2020 EMA/12150/2020.

"Ustekinumab is a monoclonal antibody and is consequently classified as a protein. According to the Guideline on the Environmental Risk Assessment on Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00), amino acids, peptides and proteins are exempted because they are unlikely to result in significant risk to the environment. Consequently, no Environmental Risk Assessment for ustekinumab is required. The CHMP considered this acceptable."

Fass environmental information

Fass environmental information for Stelara from Janssen (downloaded) 2020-05-26).

Risk

Use of amino acids, peptides and proteins has been considered to result in insignificant 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