EMA notification

The European Medicines Agency (EMA) has started a review of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg when used for acne.

These products are available in several countries in the European Union (EU) as oral contraceptives and for the treatment of moderate acne in women.

The review of these medicines has been requested by the UK’s medicines agency (MHRA) because of concerns that the benefits of dienogest/ethinylestradiol have not been sufficiently demonstrated in the treatment of acne. The MHRA was also concerned about the risk of venous thromboembolism (VTE or blood clots in veins), which has not been sufficiently characterised for this combination, and noted that alternative treatment options for acne are available.

EMA will now review all available data on the benefits and risks of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg in the treatment of acne, and will issue an opinion on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the EU. While the review is ongoing, women who have any questions should consult their doctor or pharmacist.

The press release is available by clicking here.

We would be grateful if you could disseminate this email to anyone else who might be interested in this document.

With kind regards,

Nathalie Macle

Stakeholders and Communication Division
European Medicines Agency
30 Churchill Place
London, E14 5EU
United Kingdom
Tel +44 (0)20 3660 7284