Seasonique and associated names - referral

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.

What is Seasonique?

Seasonique is an oral contraceptive for women. It is available as blister packs containing 91 tablets to be taken once a day in the order shown on the pack. For 84 days the woman takes the tablets containing levonorgestrel and ethinylestradiol and then for the remaining 7 days she takes tablets containing only ethinylestradiol.

Levonorgestrel (a progestogen) and ethinylestradiol (an oestrogen) are both hormones and Seasonique is what is known as a 'combined hormonal contraceptive'. Combined hormonal contraceptives work by stopping the release of eggs from the ovaries and by causing changes in the cervix and the lining of the womb that make it harder for a sperm to reach an egg and for a fertilised egg to implant in the womb.

Because the treatment cycle of 91 days is longer than that of most other combined contraceptives (which is normally 28 days), Seasonique is known as an extended cycle oral contraceptive. Women taking Seasonique will have longer intervals between withdrawal bleeding but may experience more irregular bleeding.

Why was Seasonique reviewed?

Teva Pharma submitted an application to the French medicines agency (ANSM) for Seasonique to be authorised in a decentralised procedure. This is a procedure where one Member State (the 'reference Member State', in this instance France) assesses a medicine with a view to granting a marketing authorisation that will be valid in that country as well as in other Member States (the 'concerned Member States', in this instance Austria, Belgium, Germany, Italy, Poland, Romania, Slovakia and Slovenia). However, the Member States were not able to reach an agreement and the French medicines agency referred the matter to the CHMP for arbitration on 3 February 2014.

The grounds for the referral related to concerns raised by the German medicines agency about the effectiveness of Seasonique in preventing pregnancy and the irregular bleeding experienced by women taking the contraceptive.

What are the conclusions of the CHMP?

After evaluating data from studies and post-marketing data from outside the EU, the CHMP was of the view that there was adequate evidence that Seasonique is an effective contraceptive. The Committee also noted that the irregular bleeding reported with Seasonique has not made women less likely to keep to their treatment and adequate information about the risk of irregular bleeding is included in the package leaflet.

The Committee therefore concluded that the benefits of Seasonique outweigh its risks and recommended that marketing authorisation be granted in the reference and concerned Member States.

The European Commission issued an EU-wide legally binding decision on 12 January 2015.

Questions and answers on Seasonique and associated names (levonorgestrel / ethinylestradiol)

Reference Number: EMA/383921/2014

Key facts

About this medicine

• Approved name:
  Seasonique and associated names
• International non-proprietary name (INN) or common name:
  • levonorgestrel
  • ethinylestradiol

About this procedure

• Current status:
  European Commission final decision
• 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.

Key dates and outcomes

• CHMP opinion date:
  20/11/2014
• EC decision date:
  12/01/2015

All documents

Opinion provided by Committee for Medicinal Products for human Use

Questions and answers on Seasonique and associated names (levonorgestrel / ethinylestradiol)

Reference Number: EMA/383921/2014

European Commission final decision

Seasonique Article-29(4) referral - Assessment report

AdoptedReference Number: EMA/CHMP/24607/2015

Seasonique Article-29(4) - Annex I

Seasonique Article-29(4) - Annex II

Seasonique Article-29(4) - Annex III

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.