Dienogest / Ethinylestradiol containing medicinal products indicated in acne

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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issue an opinion on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the EU.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.

More about the medicines

Medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg are used as oral contraceptives and for the treatment of moderate acne in women when topical treatment is ineffective. They have been authorised as Valette and other trade names via national procedures in the following EU Member States: Austria, Belgium, Bulgaria, Czech Republic, Estonia, Germany, Hungary, Latvia, Lithuania, Luxembourg, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.

Dienogest and ethinylestradiol are two types of hormones, a progestogen and an oestrogen. They work by changing the body’s hormonal balance.

More about the procedure

The review of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg for acne has been initiated at the request of the UK’s medicines agency (the Medicines and Healthcare products Regulatory Agency, MHRA), under Article 31 of Directive 2001/83/EC.

The review is being carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s final opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.

Name Language First published Last updated
Dienogest / Ethinylestradiol Article-31 referral - Review started (English only) 2016-02-26  

Key facts

Approved nameDienogest / Ethinylestradiol containing medicinal products indicated in acne
International non-proprietary name (INN) or common name

dienogest/ethinylestradiol

Associated names-
Class-
Reference numberEMEA/H/A-31/1435
TypeArticle 31 referrals

This type of referral is triggered when the interest of the Community is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

StatusUnder evaluation
Opinion date

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
Under evaluation

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