Mifepristone Linepharma - referral

Current status

European Commission final decision

Overview

On 21 June 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Mifepristone Linepharma. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Mifepristone Linepharma outweigh its risks, and recommended that the marketing authorisation granted in Sweden be recognised in other Member States of the EU.

What is Mifepristone Linepharma?

Mifepristone Linepharma is a medicine used for terminating pregnancy. It contains the active substance mifepristone, which works by blocking the effects of the hormone progesterone, which plays an important role in the maintenance of pregnancy.

Mifepristone Linepharma is given as a single dose of 200 mg, followed 36 to 48 hours later by a dose of another medicine called gemeprost.

Mifepristone Linepharma is a 'hybrid medicine'. This means that it is similar to a 'reference medicine' called Mifegyne containing the same active substance. Both medicines are available as 200-mg tablets but whereas Mifegyne was authorised to be given at doses of 600 mg and 200 mg, Mifepristone Linepharma was only authorised at the 200-mg dose.

Mifepristone Linepharma is already authorised through a decentralised procedure in Denmark, Finland, Iceland, Norway and Sweden.

Why was Mifepristone Linepharma reviewed?

Linepharma France submitted an application for Mifepristone Linepharma for mutual recognition on the basis of the initial authorisation granted by Sweden on 3 December 2010. The company wanted the authorisation to be recognised in France and the United Kingdom (the 'concerned Member States').

However, the Member States were not able to reach an agreement and the French medicines regulatory agency referred the matter to the CHMP for arbitration on 23 February 2012.

The grounds for the referral were that Mifepristone Linepharma had not been shown to be bioequivalent to the reference medicine, Mifegyne 200 mg. In addition, the available data on the safety and effectiveness of the medicine were not sufficient to compensate for the lack of bioequivalence. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the conclusions of the CHMP?

The CHMP noted that the data submitted by the company showed a small deviation of Mifepristone Linepharma from the acceptable range for bioequivalence with the reference medicine, with Mifepristone Linepharma 200 mg producing slightly higher levels of active substance in the body than Mifegyne 200 mg. However, the difference was not considered to be of concern as the safety and effectiveness of mifepristone at much higher doses of up to 600 mg is well established and has been confirmed by the supportive studies with Mifepristone Linepharma.

Therefore, based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Mifepristone Linepharma outweigh its risks and recommended that the marketing authorisation for Mifepristone Linepharma be granted in all concerned Member States. The CHMP also concluded that the product information should include a statement that doses higher than 200 mg should not be given. In addition, the Committee recommended that a prospective observational study should be performed to monitor how Mifepristone Linepharma is prescribed.

The European Commission issued a decision on 11 September 2012.

Questions and answers on Mifepristone Linepharma and associated names (mifepristone, 200-mg tablet)

Reference Number: EMA/410788/2012 Rev.1

Key facts

About this medicine

• Approved name:
  Mifepristone Linepharma
• International non-proprietary name (INN) or common name:
  mifepristone

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1331
• 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:
  21/06/2012
• EC decision date:
  11/09/2012

All documents

European Commission final decision

Mifepristone Article 29(4) referral - Annex I

Mifepristone Article 29(4) referral - Annex II

Mifepristone Article 29(4) referral - Annex III

Mifepristone Article 29(4) referral - Annex IV

Mifepristone Article 29(4) referral - Assessment report

Adopted Reference Number: EMA/556309/2012

Questions and answers on Mifepristone Linepharma and associated names (mifepristone, 200-mg tablet)

Reference Number: EMA/410788/2012 Rev.1

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.