Belanette - referral

Current status

European Commission final decision

Overview

Belanette and associated names, is a combined oral contraceptive containing 0.02 mg of ethinylestradiol and 3 mg of drospirenone.

The MAH submitted variation application subject to the Mutual Recognition Procedure to the Marketing Authorisations of the medicinal product in the framework of Article 5 of Commission Regulation (EC) No 1084/2003. The Mutual Recognition Procedure started on 18 June 2007. The Reference Member State was Netherlands and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, Spain and Sweden. These Member States were not able to reach an agreement in respect of the variation to the Marketing Authorisation within the time frame as referred to in Article 5(6) of Commission Regulation (EC) No 1084/2003. Hungary referred the reasons for disagreement to the EMEA on 12 October 2007.

The proposed package concept, the so-called wallet with the product and package leaflet wrapped in transparent cellophane was considered to be a serious public concern. The cellophane wrapping could not be accepted as an outer packaging due to the risk that during usage the product (wallets) would get separated from the package leaflet. Furthermore the Braille text could not be read through the outer packaging as the cellophane is slippery and moves when touched.

The arbitration procedure started on 18 October 2007. The Rapporteur was Dr Jean-Louis Robert and Co- Rapporteur was Dr Janos Borvendeg.

During their December 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Yasminelle and associated names, that the objections raised by Hungary should not prevent the approval of the variation applied for and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be the final versions achieved during the Coordination group procedure. A positive opinion was adopted by majority on 13 December 2007.

The list of the product names concerned is given in Annex I.

The scientific conclusions are provided in Annex II.

The final opinion was converted into a Decision by the European Commission on 17 June 2008.

Opinion following an Article 5(11) referral for Belanette and associated names (see Annex I) International Non-Proprietary Name (INN): Drospirenone + Ethinylestradiol: Background information

AdoptedReference Number: EMEA/CHMP/332403/2008

Key facts

About this medicine

• Approved name:
  Belanette
• International non-proprietary name (INN) or common name:
  • drospirenone
  • ethinyl estradiol

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/332403/08
• Type:
  Article 5(11) referrals (prior to January 2010)

  This type of referral was triggered for a medicine that had been authorised by mutual recognition or via the decentralised procedure when there was disagreement between Member States on a variation (type IB).

Key dates and outcomes

• CHMP opinion date:
  14/12/2007
• EC decision date:
  17/06/2008

All documents

Belanette - Article 5(11) referral - Annex I, II, III

Adopted

Opinion following an Article 5(11) referral for Belanette and associated names (see Annex I) International Non-Proprietary Name (INN): Drospirenone + Ethinylestradiol: Background information

AdoptedReference Number: EMEA/CHMP/332403/2008

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.