The use of contraception after treatment with genotoxic medicines: add recommendations to patient information leaflets
July 12, 2021
The FAMHP reminds marketing authorisation holders of the obligation to add recommendations on the use of contraception to the package leaflet of genotoxic medicines.
In February 2020, the European Medicines Agency published an advice, based on a request from the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), on the use of contraception in male and female patients after discontinuation of treatment with a genotoxic medicine. This recommendation applies both to clinical trials and marketing authorisation applications.