Hazard - P - B - T - Risk Exempt
This summary information comes from the assessment report for Ogivri (trastuzumab) and Fass environmental information for various drugs with trastuzumab.
Assessment report for Ogivri 18 October 2018, EMA/810499/2018. There are several assessment reports for other approved drugs with trastuzumab and this is the most recently approved.
"The applicant submitted a justification for not providing an environmental risk assessment. Trastuzumab is already used in existing marketed products and no significant increase in environmental exposure is anticipated with Ogivri. Furthermore, the "Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use" (EMENCHMP/SWP/4447/00 corr. 2*) makes specific reference for certain types of products such as proteins, that due to their nature they are unlikely to result in a significant risk to the environment. Therefore, considering that Ogivri is a protein and there is no expected increased environmental exposure, the absence of formal environmental risk assessment studies for Ogivri is considered justified."
Fass environmental information
Fass environmental information for trastuzumab (Herceptin, Kanjinti and Ontruzant) from Roche, Amgen and MSD respectively.
The use of amino acids, proteins and peptides is not considered to have any environmental impact.
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.
- European Medicines Agency, EMA: Committee for Medicinal Products for Human Use (CHMP). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. 1 June 2006.
- European Medicines Agency. European public assessment report (EPAR). Ogivri 18 October 2018, EMA/810499/2018.
- Fass för vårdpersonal.
Author: Health and Medical Care Administration, Region Stockholm