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Direct Healthcare Professional Communication (DHPC) on combined hormonal contraceptives with chlormadinone acetate/ethinyl estradiol: Slightly increased risk of venous thromboembolism

Active substance: chlormadinone acetate, ethinyl estradiol

The marketing authorization holders of combined hormonal contraceptives containing chlormadinone acetate and ethinyl estradiol, in agreement with the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices (BfArM), would like to inform that the retrospective cohort study RIVET-RCS[1] concluded that women taking combined hormonal contraceptives with the active ingredients chlormadinone acetate and ethinyl estradiol have a 1.25-fold increased risk of venous thromboembolism compared to women taking combined hormonal contraceptives with the active ingredients levonorgestrel and ethinyl estradiol.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 401KB, File is accessible