Evolokumab

Detaljerad information

Utredningsrapport Repatha, 21 maj 2015

Utredningsrapport för Repatha (evolokumab), 21 May 2015, EMA/CHMP/222019/2015.

"No ERA have been done, which is agreed seen the nature of the product. Evolocumab is a protein composed of normal amino acids and readily biodegradable. Therefore it does not pose a risk for the environment."

Utredningsrapport Repatha, 22 februari 2018

Utredningsrapport för Repatha, 22 February 2018, EMA/233126/2018.

"No environmental risk studies were included in this application. The applicant submitted a justification stating that evolocumab is considered to be a non-hazardous, biodegradable product. The environmental risk in terms of use and disposal was considered to be negligible and, therefore, did not require further testing as per the EU Enviromental Risk Assessment Guideline. Furthermore, the assessment performed does not indicate a requirement to take special precautions during the release to the environment that will result from use in patients or disposal of the product. As such, it is not considered necessary to include warnings or precautions within the product information in relation to environmental risks. The CHMP agreed with the conclusions of the Applicant."

Fass miljöinformation

Fass miljöinformation för Repatha från Amgen (hämtad 2023-09-25).

Risk

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

Detaljerad information

Enligt den europeiska läkemedelsmyndigheten EMA:s riktlinjer för miljöriskbedömningar av läkemedelssubstanser (EMA/CHMP/SWP/4447/00) är vitaminer, elektrolyter, aminosyror, peptider, proteiner, kolhydrater, lipider, vacciner och växtbaserade läkemedel undantagna då de inte bedöms medföra någon betydande risk för miljön.