Cancellation of marketing authorization for bufexamac-containing proprietary medicinal products

Based on a re-evaluation of the safety and efficacy data, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends the withdrawal of the marketing authorization for all bufexamac-containing medicinal products within the EU, as the benefit/risk ratio for these preparations is no longer given.

Information for users and patients:

• Bufexamac should no longer be prescribed effective immediately.
• Patients on current therapy with bufexamac are encouraged to contact their treating physician to discuss further action.

More information:

European Medicines Agency

Further inquiries:

AGES PharmMed

Communication

E-mail: pr_pharmmed@ages.at

Further inquiry note

basg@basg.gv.at