Bicaluplex - referral

Current status

European Commission final decision

Overview

Bicaluplex and associated names, 150 mg, film-coated tablet, is an oral anti-androgen used in the management of prostate cancer.

Ingers Industrials Solutions s.r.o submitted applications for mutual recognition of Bicaluplex and associated names, 150 mg, film-coated tablet on the basis of the marketing authorisation granted by Czech Republic on 30 November 2005. The Mutual Recognition Procedure started on 21 September 2006. The Reference Member State was Czech Republic and the Concerned Member States were Austria, Denmark, Germany, Estonia, Greece, France, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Sweden, Slovenia, Slovak Republic and the United Kingdom. These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State. Czech Republic referred the reasons for disagreement to the EMEA on 30 March 2007.

Significant differences have been identified with regard to the benefit/risk ratio of the product. This refers to two indications (treatment of locally advanced prostatic carcinoma without metastases, for which surgical castration or other type of medical intervention is not indicated or unacceptable; and as monotherapy in early treatment or as an adjunct to treatment with radiotherapy or radical prostatectomy in patients with prostatic carcinoma (T3-T4, any Stage N, M0) and this was considered to be of serious public health concern.

The arbitration procedure started on 26 April 2007 with the adoption of a list of questions. The Rapporteur was Dr Ondrej Slanar and Co-Rapporteur was Dr Matthew Thatcher. The Marketing Authorisation Holder provided written explanations on 20 July 2007.

During their September 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 Bicaluplex and associated names, that the objections raised by Germany should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended. A positive opinion was adopted by consensus on 20 September 2007.

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

The final opinion was converted into a Decision by the European Commission on 22 November 2007.

Opinion following an Article 29(4) referral for Bicaluplex and associated names International Non-Proprietary Name (INN): bicalutamide: Background information

Adopted Reference Number: EMEA/433691/2007

Key facts

About this medicine

• Approved name:
  Bicaluplex
• International non-proprietary name (INN) or common name:
  bicalutamide

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/433691/07
• 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:
  20/09/2007
• EC decision date:
  22/11/2007

All documents

Bicaluplex - Article 29 referral - Annex I, II, III, IV

Adopted

Opinion following an Article 29(4) referral for Bicaluplex and associated names International Non-Proprietary Name (INN): bicalutamide: Background information

Adopted Reference Number: EMEA/433691/2007

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.