Rigevidon - referral

Current status

European Commission final decision

Overview

Rigevidon is a combined oral contraceptive (COC) containing 150μg levonorgestrel (LNG) and 30μg ethinylestradiol (EE2).

A Marketing Authorisation for Rigevidon was granted to Medimpex France SA by Denmark on 10 March 2003. The application for Mutual Recognition for Rigevidon was submitted to Denmark and the Mutual Recognition Procedure started on 30 April 2004.

The referral procedure was triggered by the Netherlands, in relation to the acceptance criteria, in bioequivalence studies, of pharmacokinetics parameters, which may need to be tightened, if Rigevidon could be considered as a medicinal product with a narrow therapeutic range. The arbitration procedure started on 16 September 2004.

During its January 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that a marketing authorisation should be granted. A positive opinion was therefore adopted on 20 January 2005.

The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the Summary of Product Characteristics in the Annex III.

The final opinion was converted into a Decision by the European Commission on 10 May 2005.

Opinion following an Article 29(2) referral Rigevidon International Non-Proprietary Name (INN): levonorgestrel and ethinylestradiol: Background information

Adopted Reference Number: EMEA/CHMP/94618/2005

Key facts

About this medicine

• Approved name:
  Rigevidon
• International non-proprietary name (INN) or common name:
  • levonorgestrel
  • ethinylestradiol

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/94618/05
• 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:
  21/01/2005
• EC decision date:
  10/05/2005

All documents

Rigevidon - Article 29 referral - Annex I, II, III

Adopted

Opinion following an Article 29(2) referral Rigevidon International Non-Proprietary Name (INN): levonorgestrel and ethinylestradiol: Background information

Adopted Reference Number: EMEA/CHMP/94618/2005

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.