Dienogest/ethinylestradiol-containing medicinal products indicated in acne

Current status:
European Commission final decision

Overview

Dienogest/ethinylestradiol can be used for acne after certain other treatments have failed

Use should be limited to women who choose oral contraception

On 26 January 2016, the European Medicines Agency (EMA) recommended that medicines containing a combination of dienogest 2 mg and ethinylestradiol 0.03 mg can continue to be used to treat moderate acne when suitable treatments applied to the skin or antibiotics taken by mouth have not worked. However, these medicines, which are also approved as hormonal contraceptives, should only be used in women who choose oral contraception.

Having evaluated the existing data on the effectiveness of the combination in the treatment of acne, EMA's Committee for Medicinal Products for Human Use (CHMP) concluded that there is sufficient evidence to support its use in moderate acne. Regarding the risk of side effects, the CHMP considered that the available data do not raise any new safety concern. The known risk of venous thromboembolism (VTE or blood clots in veins), which can occur with all combined hormonal contraceptives, is considered low. However, the data on the risk with dienogest/ethinylestradiol are not sufficient to accurately estimate how it compares with other contraceptives and further data are still awaited.

Considering the observed benefits of dienogest/ethinylestradiol in the treatment of acne, the potential risk of VTE and the nature of the disease, the CHMP concluded that this combination should only be used after certain other treatments have failed, and only when oral contraception is chosen. The CHMP also recommended that women should be assessed by their doctor 3 to 6 months after starting treatment and periodically thereafter to review the need for continuation of treatment.

The prescribing information for these medicines will be updated in line with the above recommendations.

Key facts

Approved name
Dienogest/ethinylestradiol-containing medicinal products indicated in acne
International non-proprietary name (INN) or common name
dienogest / ethinylestradiol
Class
-
Reference number
EMEA/H/A-31/1435
Type
Article 31 referrals

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

Status
European Commission final decision
Opinion date
26/01/2017
EC decision date
22/03/2017

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 havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

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