Deletion of references relating to beneficial effects in acne (Indication/Properties) due to the increased risk of venous thromboembolism (VTE) in CHC users.
25.11.2015 –Swissmedic co-ordinates the information on the above-mentioned issue in order to simplify the process, since the important notice concerns several authorisation holders: Actavis Switzerland AG, Bayer (Switzerland) AG, Berlis AG, Dermapharm AG, Effik SA, Gedeon Richter (Switzerland) AG, Mepha Pharma AG, Sandoz Pharmaceuticals AG, Spirig Healthcare AG.
- References relating to beneficial effects in acne are deleted in the product information for CHCs with antiandrogenic properties (CHCs containing chlormadinone acetate or drospirenone). Such references have to date been included for these preparations in the sections "Indications/Uses" and "Properties/Effects" The reason for the deletion is the increased VTE risk in all CHC users compared to non-users.
- CHCs containing chlormadinone acetate or drospirenone are authorised for contraception and should not be used for acne.
- Alternative preparations that pose no increased risk of VTE are available for the treatment of acne.
For detailed information please see pdf document for download.