Dienogest/ethinylestradiol-containing medicinal products indicated in acne

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
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

About this medicine
Approved name
Dienogest/ethinylestradiol-containing medicinal products indicated in acne
International non-proprietary name (INN) or common name
  • dienogest
  • ethinyl estradiol
Class
-
About this procedure
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
Key dates and outcomes
CHMP opinion date
26/01/2017
EC decision date
22/03/2017

All documents

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

  • Overview - lay-language summary of the stage of the procedure
  • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
  • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
  • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
  • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
  • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
  • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
  • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
  • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
  • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
  • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
  • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
  • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
  • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
  • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.

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