Lansoprazole - referral

Current status

European Commission final decision

Overview

Lansoprazole 15 & 30 mg gastro-resistant capsules, hard are generic preparations containing lansoprazole as the active substance. Lansoprazole is a proton pump inhibitor that inhibits gastric acid secretion and is used for the treatment of duodenal and benign gastric ulcers, gastro-oesophageal reflux disease and associated conditions.

TEVA UK Limited submitted applications for mutual recognition of Lansoprazole and associated names, 15 and 30 mg, gastro-resistant capsules, hard, on the basis of the marketing authorisation granted by the United Kingdom on 9 December 2005. The Mutual Recognition Procedure started on 07 June 2006. The Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, the Netherlands, Norway, Poland, Portugal, the Slovak Republic, Spain and Sweden. 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. The Czech Republic, Spain and Portugal referred the reasons for disagreement to the EMEA on 30 November 2006.

The reasons for disagreement were, that some Member States have raised public health objections on the grounds that while bioequivalence was proven in the fasting state, the same was not the case under fed conditions.

The arbitration procedure started on 14 December 2006 with the adoption of a list of questions. The Rapporteur was Dr. Frits Lekkerkerker and Co-Rapporteur was Dr. Ian Hudson. The Marketing Authorisation Holder provided written explanations on 30 March 2007.

During their 18 – 21 June 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 Lansoprazole and associated names, that the objections raised by the Czech Republic, Spain and Portugal should not prevent the granting of a Marketing Authorisation and that the valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure. A positive opinion was adopted by consensus on 21 June 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 18 September 2007.

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

Adopted Reference Number: EMEA/283378/2007

Key facts

About this medicine

• Approved name:
  Lansoprazole
• International non-proprietary name (INN) or common name:
  lansoprazole

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/283378/07
• 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:
  21/06/2007
• EC decision date:
  18/09/2007

All documents

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

Adopted

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

Adopted Reference Number: EMEA/283378/2007

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.