BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Bufexamac products for topical use: Revocation of authorisations in the EU because of unfavourable benefit-risk ratio

Active substance: bufexamac

Assessment of medicinal products containing bufexamac for topical use in the authorised indications has revealed a negative overall benefit-risk ratio. Therefore the authorisations are revoked

risk information - full text (available in German only)