Combined hormonal contraceptives

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
Current status
European Commission final decision

Overview


Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks

Product information updated to help women make informed decisions about their choice of contraception

On 21 November 2013, the European Medicines Agency completed its review of combined hormonal contraceptives (CHCs), particularly of the risk of venous thromboembolism (VTE or blood clots in veins) associated with their use. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of CHCs in preventing unwanted pregnancies continue to outweigh their risks, and that the well-known risk of VTE with all CHCs is small.

The review has reinforced the importance of ensuring that clear and up-to-date information is provided to women who use these medicines and to the healthcare professionals giving advice and clinical care.

The product information of CHCs has been updated to help women make informed decisions about their choice of contraception together with their healthcare professional. It is important that women are made aware of the risk of VTE and its signs and symptoms, and that doctors take into consideration a woman's individual risk factors when prescribing a contraceptive. Doctors should also consider how the risk of VTE with a particular CHC compares with other CHCs (see table below).

The review also looked at the risk of arterial thromboembolism (ATE, blood clots in arteries, which can potentially cause a stroke or heart attack). This risk is very low and there is no evidence for a difference in the level of risk between products depending on the type of progestogen.

The CHMP opinion, in agreement with the previous recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), was sent to the European Commission, which adopted on 16 January 2014 a legally binding decision to update the product information of all CHCs throughout the EU.

Key facts

About this medicine
Approved name
Combined hormonal contraceptives
International non-proprietary name (INN) or common name
  • desogestrel
  • gestodene
  • norgestimate
  • etonogestrel
  • drospirenone
  • dienogest
  • chlormadinone
  • nomegestrol
  • norelgestromin
Class
-
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1356
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.

Authorisation model
Centrally and nationally authorised products (mixed)
Decision making model
PRAC-CHMP-EC
Key dates and outcomes
Procedure start date
07/02/2013
PRAC recommendation date
10/10/2013
CHMP opinion/CMDh position date
16/01/2014
Outcome
Risk minimisation measures

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Opinion provided by Committee for Medicinal Products for Human Use

European Commission final decision

  • List item

    Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks (PDF/90.43 KB)


    First published: 31/01/2014
    Last updated: 31/01/2014

  • List item

    Combined hormonal contraceptives Article-31 referral - Annex IV (PDF/19.91 KB)


    First published: 31/01/2014
    Last updated: 31/01/2014

  • List item

    Combined hormonal contraceptives Article-31 referral - Annex II (PDF/49.08 KB)


    First published: 31/01/2014
    Last updated: 31/01/2014

  • List item

    Combined hormonal contraceptives Article-31 referral - Annex I (PDF/3.74 MB)


    First published: 31/01/2014
    Last updated: 31/01/2014

  • List item

    Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks (PDF/90.43 KB)


    First published: 31/01/2014
    Last updated: 31/01/2014

  • List item

    Combined hormonal contraceptives Article-31 referral - Annex III (PDF/937.61 KB)


    First published: 31/01/2014
    Last updated: 31/01/2014

  • 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.

    How useful was this page?

    Add your rating
    Average
    1 rating
    4 ratings