Seasonique and associated names
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
On 26 June 2014, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the oral contraceptive Seasonique. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Seasonique outweigh its risks and that marketing authorisation should be granted in France and in the following EU Member States: Austria, Belgium, Germany, Italy, Poland, Romania, Slovakia and Slovenia.
Key facts
Approved name |
Seasonique and associated names
|
International non-proprietary name (INN) or common name |
levonorgestrel / ethinylestradiol |
Reference number |
EMEA/H/A-29/139
|
Type |
Article 29(4) referrals
This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health. |
Status |
European Commission final decision
|
Opinion date |
20/11/2014
|
EC decision date |
12/01/2015
|
All documents
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Questions and answers on Seasonique and associated names (levonorgestrel / ethinylestradiol) (PDF/92.64 KB)
First published: 27/06/2014
Last updated: 29/01/2015
EMA/383921/2014 -
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Seasonique Article-29(4) referral - Assessment report (PDF/177.26 KB)
Adopted
First published: 27/01/2015
Last updated: 29/01/2015
EMA/CHMP/24607/2015 -
List item
Seasonique Article-29(4) - Annex I (PDF/69.86 KB)
First published: 27/01/2015
Last updated: 29/01/2015 -
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List item
Seasonique Article-29(4) - Annex II (PDF/93.95 KB)
First published: 27/01/2015
Last updated: 29/01/2015 -
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List item
Seasonique Article-29(4) - Annex III (PDF/50.07 KB)
First published: 27/01/2015
Last updated: 29/01/2015 -
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 havebeen recommended by the Committee
- Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies