Emergency contraceptives

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


On 24 July 2014, the European Medicines Agency concluded its review of emergency contraceptives containing levonorgestrel or ulipristal acetate to assess whether increased bodyweight affects the effectiveness of these medicines in preventing unintended pregnancy following unprotected sexual intercourse or contraceptive failure. The Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that these emergency contraceptives could continue to be used in women of all weights as the benefits were considered to outweigh the risks.

In November 2013, following a national procedure, the product information of one emergency contraceptive containing levonorgestrel, Norlevo, was updated on the basis of results from two clinical studies to state that Norlevo is less effective in women weighing 75 kg or more and not effective in women weighing more than 80 kg. An EU-wide review was then started to assess whether similar information should be included in the product information for other emergency contraceptives that contain levonorgestrel, and for ellaOne, an emergency contraceptive that contains ulipristal acetate.

Having assessed all the available evidence on the effectiveness of emergency contraceptives, the CHMP considered that the data available are too limited and not robust enough to conclude with certainty that contraceptive effect is reduced with increased bodyweight, as stated in the product information for Norlevo. For levonorgestrel-containing products, some clinical studies have suggested a reduced effectiveness in women with high bodyweight, but in others no trend for a reduced effect with increasing bodyweight was observed. Similarly, for ulipristal acetate, although limited data from clinical trials suggest a possible trend for a reduced contraceptive effect, the data are too limited and insufficiently precise to draw definite conclusions. The CHMP recommended that the results of these studies should be included in the product information of emergency contraceptives, but that the statements on the impact of bodyweight in the product information for Norlevo should be deleted.

The CHMP considered that, with side effects generally mild, the safety profile of emergency contraceptives is favourable and they can continue to be taken regardless of the woman's bodyweight. Women should be reminded that emergency contraceptives should be taken as soon as possible following unprotected sexual intercourse. They should only be used as an occasional 'rescue' method as they do not work as well as regular contraceptive methods.

The CHMP recommendation was sent to the European Commission, which issued a legally binding decision valid throughout the EU on 30 September 2014.

Key facts

About this medicine
Approved name
Emergency contraceptives
International non-proprietary name (INN) or common name
  • levonorgestrel
  • ulipristal acetate
Associated names
  • Norlevo
  • Levonelle/Postinor and Levodonna
  • ellaOne
About this procedure
Current status
European Commission final decision
Reference number
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.

Key dates and outcomes
CHMP opinion date
EC decision date

All documents

Procedure started

Opinion provided by Committee for Medicinal Products for Human Use

European Commission final decision

  • List item

    Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight (PDF/102.13 KB)


    First published: 24/10/2014
    Last updated: 24/10/2014

  • List item

    Emergency contraceptives Article-31 referral - CHMP assessment report (PDF/471.4 KB)

    First published: 24/10/2014
    Last updated: 24/10/2014

  • List item

    Emergency contraceptives Article-31 referral - Annex I (PDF/110.56 KB)

    First published: 24/10/2014
    Last updated: 24/10/2014

  • List item

    Emergency contraceptives Article-31 referral - Annex II (PDF/60.05 KB)

    First published: 24/10/2014
    Last updated: 24/10/2014

  • List item

    Emergency contraceptives Article-31 referral - Annex III (PDF/34.99 KB)

    First published: 24/10/2014
    Last updated: 24/10/2014

  • 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.

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