Tenecteplase

Detailed information

Assessment report

Assessment report for Metalyse (tenecteplase), 14 December 2023, EMA/37096/2024.

"The applicant provided a justification for not submitting an updated Environmental Risk Assessment in accordance with the CHMP guideline EMEA/CHMP/SWP/4447/00. Tenecteplase is an antithrombotic agent administered intravenously via bolus injection currently approved for patients with acute myocardial infarction. TNK is a non-toxic glycoprotein consisting only of natural amino acids and carbohydrates being readily metabolised and biodegraded. In accordance with the CHMP Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00 corr 2, 01 June 2006), an ERA is not required for proteins, amino acids, and carbohydrates, as they are considered to be unlikely to result in significant risk to the environment due to the nature of their constituents; they are generally exempted from the requirement to file a complete Phase I & II ERA. Therefore, an environmental risk assessment is not provided of the intended new indication for Metalyse. This is considered acceptable. Tenecteplase is not expected to pose a risk to the environment."

Fass environmental information

Fass environmental information for Metalyse from Boehringer Ingelheim (downloaded 2019-09-02).

Risk

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 proteins, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment.