Ethinylestradiol-Drospirenone 24+4
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
On 19 April 2012, the European Medicines Agency completed an arbitration procedure for Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4. The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to consider a proposed change to the marketing authorisations for these medicines to include a new indication for the treatment of moderate acne in women seeking oral contraception. The Committee concluded that the change to the marketing authorisations cannot be granted.
Key facts
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About this medicine
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|---|---|
| Approved name |
Ethinylestradiol-Drospirenone 24+4
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| International non-proprietary name (INN) or common name |
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| Associated names |
Yaz 24+4
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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-6(12)/1313
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| Type |
Article 6(12) referrals (prior to January 2010)
This type of referral was triggered for a medicine that had been authorised by mutual recognition or via the decentralised procedure when there was disagreement between Member States on a variation (type II). This referral has been replaced by Article 13 referrals. |
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Key dates and outcomes
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|---|---|
| CHMP opinion date |
19/04/2012
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| EC decision date |
06/07/2012
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All documents
European Commission final decision
Ethinylestradiol-Drospirenone 24+4 Article-6(12) referral - Annex I (PDF/42.23 KB)
First published: 11/01/2013
Last updated: 11/01/2013
Ethinylestradiol-Drospirenone 24+4 Article-6(12) referral - Annex II (PDF/70.3 KB)
First published: 11/01/2013
Last updated: 11/01/2013
Ethinylestradiol-Drospirenone 24+4 Article-6(12) referral - Assessment report (PDF/211.2 KB)
First published: 11/01/2013
Last updated: 11/01/2013
EMA/399943/2012
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.