Dienogest/ethinylestradiol-containing medicinal products indicated in acne

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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.

Information for patients
  • Medicines containing dienogest and ethinylestradiol should only be used to treat moderate acne in women who also choose oral contraception. They should only be used when treatments applied to the skin or an antibiotic taken by mouth have not worked.
  • You should be aware that, as with other hormonal contraceptives, there is a risk of blood clots associated with the use of dienogest/ethinylestradiol. While this risk is low, the data on the risk with dienogest/ethinylestradiol are still insufficient to accurately estimate how it compares with other contraceptives.
  • When taking dienogest/ethinylestradiol, you should be alert to the signs and symptoms of blood clots in veins, which may include severe pain or swelling in the legs, sudden unexplained breathlessness, rapid breathing or cough, chest pain, and weakness or numbness of the face, arms or legs. If you develop any of these signs and symptoms you should seek medical advice immediately.
  • Your acne will usually improve after 3 to 6 months of treatment with dienogest/ethinylestradiol. Your doctor will assess whether you should continue treatment with this medicine 3 to 6 months after you have started treatment and regularly after that.
  • If you have any questions or concerns, speak with your doctor, pharmacist or nurse.
Information for healthcare professionals
  • The combination dienogest/ethinylestradiol should be used for the treatment of moderate acne only after failure of suitable local therapies or oral antibiotic treatment in women who elect to use an oral contraceptive.
  • Data from two phase III trials (study no. A07062 and A28501) in a total of around 2,400 women (mostly with moderate acne) showed that dienogest/ethinylestradiol was more effective than placebo and at least as effective as ethinylestradiol/norgestimate and ethinylestradiol/cyproterone at treating acne in terms of changes in inflammatory lesion count, total lesion count and improvement of facial acne according to IGA (Investigator’s Global Assessment).
  • It is not known how the efficacy of dienogest/ethinylestradiol compares with other acne treatments, i.e. topical treatments and systemic antibiotics.
  • The currently available safety data do not raise any new safety concerns. However, to date, there are insufficient data to accurately determine the relative risk of venous thromboembolism (VTE) with respect to other combined hormonal contraceptives containing other progestogens.
  • Taking into account the available evidence, and in order not to unnecessarily expose women to a potentially higher risk of VTE, use of dienogest/ethinylestradiol should be restricted to second line and to women who also choose oral contraception.
  • Since improvement of acne usually requires at least 3 months of treatment with dienogest/ethinylestradiol and further improvement has been seen after 6 months, women should be assessed 3 to 6 months after treatment initiation and periodically thereafter to review the need for continuation of treatment.
More about the medicine

Medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg are used as oral contraceptives and for the treatment of moderate acne. They have been authorised for up to 20 years 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 blocking the effects of a class of hormones called androgens. This alters the production of oils in the skin and also suppresses ovulation.

More about the procedure

The review of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg for acne was initiated on 25 February 2016 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 was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency’s opinion. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States. Commission decision date: 22/03/2017.

Name Language First published Last updated
Dienogest/ethinylestradiol can be used for acne after certain other treatments have failed (English only) 2017-01-27 2017-03-24

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.

StatusEuropean Commission final decision
Opinion date26/01/2017

All documents

Name Language First published Last updated
Dienogest/ethinylestradiol can be used for acne after certain other treatments have failed (English only) 2017-01-27 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Assessment report (English only) 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Amended product information (English only) 2017-01-27  
Dienogest / Ethinylestradiol Article-31 referral - Review started (English only) 2016-02-26  
Dienogest / Ethinylestradiol Article-31 referral - CHMP list of questions (English only) 2016-02-26  
Dienogest / Ethinylestradiol Article-31 referral - Timetable for the procedure (English only) 2016-02-26 2016-12-16
Dienogest / Ethinylestradiol Article-31 referral - Notification (English only) 2016-02-26  
Dienogest / Ethinylestradiol Article-31 referral - Annex I BG = bălgarski 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I ES = español 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I CS = čeština 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I DA = dansk 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I DE = Deutsch 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I ET = eesti keel 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I EL = elliniká 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I EN = English 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I FR = français 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I IT = italiano 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I LV = latviešu valoda 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I LT = lietuvių kalba 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I HU = magyar 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I MT = Malti 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I NL = Nederlands 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I PL = polski 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I PT = português 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I RO = română 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I SK = slovenčina 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I SL = slovenščina 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I FI = suomi 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I SV = svenska 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I HR = Hrvatski 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I IS = Islenska 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex I NO = Norsk 2016-03-16 2017-03-24
Dienogest / Ethinylestradiol Article-31 referral - Annex II BG = bălgarski 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II ES = español 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II CS = čeština 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II DA = dansk 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II DE = Deutsch 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II ET = eesti keel 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II EL = elliniká 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II EN = English 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II FR = français 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II IT = italiano 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II LV = latviešu valoda 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II LT = lietuvių kalba 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II HU = magyar 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II MT = Malti 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II NL = Nederlands 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II PL = polski 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II PT = português 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II RO = română 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II SK = slovenčina 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II SL = slovenščina 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II FI = suomi 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II SV = svenska 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex II HR = Hrvatski 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III BG = bălgarski 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III ES = español 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III CS = čeština 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III DA = dansk 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III DE = Deutsch 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III ET = eesti keel 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III EL = elliniká 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III EN = English 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III FR = français 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III IT = italiano 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III LV = latviešu valoda 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III LT = lietuvių kalba 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III HU = magyar 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III MT = Malti 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III NL = Nederlands 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III PL = polski 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III PT = português 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III RO = română 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III SK = slovenčina 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III SL = slovenščina 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III FI = suomi 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III SV = svenska 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III HR = Hrvatski 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III IS = Islenska 2017-03-24  
Dienogest / Ethinylestradiol Article-31 referral - Annex III NO = Norsk 2017-03-24  

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:
European Commission final decision

More information on dienogest/ethinylestradiol-containing medicinal products indicated in acne