Alendronate HEXAL - referral

Current status

European Commission final decision

Overview

Alendronate HEXAL and associated names, 10 mg tablets, contains alendronic acid as sodium alendronate trihydrate, which is a bisphosphonate indicated in the treatment of post-menopausal osteoporosis.

Hexal A/S submitted applications for mutual recognition of Alendronate HEXAL and associated names, 10 mg tablets on the basis of the marketing authorisation granted by Sweden on 3 December 2004. The Reference Member State was Sweden and in the first wave of the mutual recognition procedure, the concerned Member States which have already granted the marketing authorisation were Germany and Poland. In the repeat use of the Mutual Recognition procedure, which started on 11 October 2005, the application was submitted to the Concerned Member States (CMS): Belgium, Greece and Denmark. 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. Sweden referred the reasons for disagreement to the EMEA on 10 July 2006.

Significant difference has been identified with regard to the indication for treatment of osteoporosis in men and this was considered to be of serious public health concern.

The arbitration procedure started on 27 July 2006 with the adoption of a list of questions. The Rapporteur was Dr. Tomas Salmonson and Co-Rapporteur(s) was Dr. Frits Lekkerkerker. The Marketing Authorisation Holder provided written explanations on 19 October 2006.

During their January 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 objections that triggered the Article 29 Referral, should not prevent the granting of a Marketing Authorisation for Alendronate HEXAL and associated names. The CHMP considered that the benefit/risk ratio was considered to be favourable in the following indication: “Treatment of osteoporosis in men at increased risk of fracture. A reduction in the incidence of vertebral, but not of non-vertebral fractures has been demonstrated”. Therefore the CHMP issued a positive opinion on 24 January 2007 recommending the granting of the Marketing Authorisation and the amendments of the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State.

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 13 April 2007.

Opinion following an Article 29(4) referral for Alendronate HEXAL and associated names International Non-Proprietary Name (INN): alendronic acid (as sodium alendronate trihydrate): Background information

AdoptedReference Number: EMEA/CHMP/75285/2007

Key facts

About this medicine

• Approved name:
  Alendronate HEXAL
• International non-proprietary name (INN) or common name:
  alendronic acid (as sodium alendronate trihydrate)

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/75285/07
• 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:
  25/01/2007
• EC decision date:
  13/04/2007

All documents

Alendronate HEXAL- Article 29 referral - Annex I, II, III

Adopted

Opinion following an Article 29(4) referral for Alendronate HEXAL and associated names International Non-Proprietary Name (INN): alendronic acid (as sodium alendronate trihydrate): Background information

AdoptedReference Number: EMEA/CHMP/75285/2007

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.