Seasonique and associated names

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

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

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:

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