Erlotinib
Summary
Persistence. It cannot be excluded that erlotinib is persistent, as data are lacking.
Bioaccumulation. It cannot be excluded that erlotinib bioaccumulates, as data are lacking.
Toxicity. It cannot be excluded that erlotinib is toxic, as data are lacking.
Risk. Risk of environmental impact of erlotinib cannot be excluded, due to the lack of environmental toxicity data.
Environmental information is missing on fass.se for erlotinib (2025-06-27).
Detailed information
EMA's scientific discussion Tarceva
EMA's scientific discussion for Tarceva (erlotinib) 03/11/2005.
"Considering ecotoxicological and environmental fate properties as well as use pattern, dosage and maximal estimated amounts of erlotinib to be placed on the market, no exposure levels of concern to the environment are to be expected." No data are available.
Assessment report Tarceva 2010
Assessment report for Tarceva London, 27 April 2010, Doc. Ref No.EMA/CHMP/298837/2010.
"With this application, the MAH submitted an expert report addressing the ERA for erlotinib. No significant risk to sewage treatment plants, surface waters and groundwater has been identified from the use of erlotinib. Final conclusions concerning the effects of erlotinib on sediment organisms will be provided as a post-authorisation commitment."
Assessment report Tarceva 2011
Assessment report for Tarceva, type II variation, 21 July 2011, EMA/657134/2011.
"The estimated future environmental exposure in terms of surface water PEC to erlotinib even assuming a doubling of the use of erlotinib will be around 100 times lower than estimated in the first ERA and similarly for the other dependent PEC values and the risk ratios including the one for sediment. Therefore, the justification for not submitting a new ERA in the current application is deemed acceptable."
Comment
No additional information on the environmental risk assessment for erlotinib has been found on the EMA website (2025-06-27).
References
- EMA's scientific discussion for Tarceva (erlotinib) 03/11/2005.
- European Medicines Agency. European public assessment report (EPAR) for Tarceva London, 27 April 2010, Doc. Ref No.EMA/CHMP/298837/2010.
- European Medicines Agency. European public assessment report (EPAR) for Tarceva, type II variation, 21 July 2011, EMA/657134/2011.
Author: Health and Medical Care Administration, Region Stockholm