Combined hormonal contraceptives
- Procedure started
- Under evaluation
- PRAC recommendation
- CHMP opinion
- European Commission final decision
Table of contents
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
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Approved name |
Combined hormonal contraceptives
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International non-proprietary name (INN) or common name |
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Class |
-
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About this procedure
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Current status |
European Commission final decision
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Reference number |
EMEA/H/A-31/1356
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Type | |
Authorisation model |
Centrally and nationally authorised products (mixed)
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Decision making model |
PRAC-CHMP-EC
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Key dates and outcomes
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Procedure start date |
07/02/2013
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PRAC recommendation date |
10/10/2013
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CHMP opinion/CMDh position date |
16/01/2014
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Outcome |
Risk minimisation measures
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All documents
Procedure started
Combined hormonal contraceptives: Article-31 referral - Review started (PDF/83.28 KB)
First published: 08/02/2013
Last updated: 08/02/2013
EMA/75551/2013
Combined hormonal contraceptives Article-31 referral - Annex I (PDF/2.4 MB)
First published: 08/02/2013
Last updated: 11/03/2013
EMA/713187/2012 Rev 1
Combined hormonal contraceptives: Article-31 referral - PRAC list of questions (PDF/85.58 KB)
First published: 08/02/2013
Last updated: 13/02/2013
EMA/PRAC/60232/2013
Combined hormonal contraceptives: Article-31 referral - Notification (PDF/1.08 MB)
First published: 08/02/2013
Last updated: 08/02/2013
Combined hormonal contraceptives: Article-31 referral - Timetable for the procedure (PDF/70.51 KB)
First published: 08/02/2013
Last updated: 12/07/2013
EMA/PRAC/122032/2013 - Rev 3
Recommendation provided by Pharmacovigilance Risk Assessment Committee
Combined hormonal contraceptives Article-31 referral - PRAC assessment report (PDF/331.07 KB)
First published: 31/01/2014
Last updated: 31/01/2014
PRAC confirms that benefits of all combined hormonal contraceptives (CHCs) continue to outweigh risks (PDF/76.51 KB)
First published: 11/10/2013
Last updated: 11/10/2013
EMA/607314/2013
Opinion provided by Committee for Medicinal Products for Human Use
Combined hormonal contraceptives Article-31 referral - CHMP divergent position to PRAC (PDF/31.94 KB)
First published: 31/01/2014
Last updated: 31/01/2014
Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks – CHMP endorses PRAC recommendation (PDF/81.04 KB)
First published: 22/11/2013
Last updated: 22/11/2013
EMA/709120/2013
European Commission final decision
Combined hormonal contraceptives Article-31 referral - Annex IV (PDF/19.91 KB)
First published: 31/01/2014
Last updated: 31/01/2014
Combined hormonal contraceptives Article-31 referral - Annex II (PDF/49.08 KB)
First published: 31/01/2014
Last updated: 31/01/2014
Combined hormonal contraceptives Article-31 referral - Annex I (PDF/3.74 MB)
First published: 31/01/2014
Last updated: 31/01/2014
Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks (PDF/90.43 KB)
First published: 31/01/2014
Last updated: 31/01/2014
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.