Lansoprazol-ratiopharm 15 mg and 30 mg - referral

Current status

European Commission final decision

Overview

Lansoprazol-ratiopharm (lansoprazole) is a proton pump inhibitor that inhibits gastric acid secretion and is used for treatment of duodenal and gastric ulcer, reflux oesophagitis, gastro-oesophageal reflux disease, treatment and prophylaxis of NSAID-associated gastric and duodenal ulcers, Zollinger-Ellison syndrome, and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.

A Marketing Authorisation for Lansoprazol-ratiopharm (15 mg and 30 mg) was previously granted to ratiopharm GmbH in Finland on 7 November 2003. A Mutual Recognition Procedure was started on 16 September 2004. The Reference Member State was Finland and the Concerned Member States were Austria, Belgium, Denmark, Germany, Italy, Luxembourg, the Netherlands, Portugal, Sweden and United Kingdom. The Concerned Member States have not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State. The application was withdrawn in the Netherlands and United Kingdom. Portugal and Germany referred the reasons for disagreement to the EMEA on 15 December 2004.

Significant differences in comparison to the reference product have been identified with regard to the indication section of the SPCs. For the 15 mg dosage form the therapeutic indication “Helicobacter pylori eradication” is not approved for the reference medicinal product marketed in Portugal. The applicant should provide clinical data to support the use of 15 mg capsules for Helicobacter pylori eradication. In particular, the data of the bioequivalence of the 2x15 mg capsules and the 30 mg capsules, and the possible need for a reduced dose of lansoprazole in this therapeutic indication.

Significant differences in comparison to the reference product have been identified with regard to the posology section of the SPCs. The SPC of the reference product in Germany contains specific doses and dosing schedules for the combinations of lansoprazole and antibiotics recommended for eradication of Helicobacter pylori.

The arbitration procedure started on 20 January 2005. The Rapporteur and Co-Rapporteur appointed were Sif Ormarsdottir/Tomas Salmonson, Gottfried Kreutz/Julia Dunne respectively. The Marketing Authorisation Holder provided written explanations on 20 July 2005.

During its September 2005 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 Lansoprazol-ratiopharm. Changes to the SPC section 4.2 (Posology and Methods of Administration) giving a detailed dosing recommendation for antibiotics, in accordance with “Points to consider on wording of Helicobacter pylori eradication therapy in selected SPC sections”, were agreed by CHMP and a positive opinion was adopted on 15 September 2005.

The list of 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 21 February 2006.

Opinion following an Article 29(2) referral for Lansoprazol-ratiopharm 15 mg and 30 mg International Non-Proprietary Name (INN): Lansoprazole: Background information

AdoptedReference Number: EMEA/CHMP/373061/2005

Key facts

About this medicine

• Approved name:
  Lansoprazol-ratiopharm 15 mg and 30 mg
• International non-proprietary name (INN) or common name:
  Lansoprazole

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/373061/05
• 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:
  15/09/2005
• EC decision date:
  21/02/2006

All documents

Lansoprazol-ratiopharm 15 mg and 30 mg - Article 29 referral - Annex I, II, III

Adopted

Opinion following an Article 29(2) referral for Lansoprazol-ratiopharm 15 mg and 30 mg International Non-Proprietary Name (INN): Lansoprazole: Background information

AdoptedReference Number: EMEA/CHMP/373061/2005

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.