Agopton - referral

Current status

European Commission final decision

Overview

Agopton and associated names (lansoprazole) is a proton-pump inhibitor, which inhibits gastric acid secretion and therefore reduces the acid secretion of parietal cells. Lansoprazole is used for the treatment of diseases whose treatment is associated with the suppression of acid secretion in the stomach. Agopton and associated names is indicated for the treatment of peptic ulcers, reflux oesophagitis, and Zollinger-Ellison syndrome, the treatment and prophylaxis of NSAID-induced ulcers, and, in combination with antibiotics, for the eradication of Helicobacter pylori.

Agopton and associated names (lansoprazole) had been authorised via national procedures in 16 European Union Member States as well as in Iceland, Liechtenstein and Norway. As a consequence of the national procedures the medicinal product did not have the same Summary of Product Characteristics (SPC) across the European Union Member States as well as in Iceland and Norway. This became obvious in mutual recognition procedures for other lansoprazole containing products in which the involved member states could not agree on the therapeutic indications and posology because the differences between the national authorisations of the reference product Agopton, Wyeth Lederle Nordiska AB.

The referral procedure started on 17 March 2005. During its meeting on 18-21 September 2006 the CHMP, having considered the Rapporteur and the Co-Rapporteur assessment reports, the scientific discussion within the Committee and the comments from the Marketing Authorisation Holders (MAH), was of the opinion that the benefit/risk ratio of Agopton and associated names is considered to be positive for the following indications:

• Treatment of duodenal and gastric ulcer
• Treatment of reflux oesophagitis
• Prophylaxis of reflux oesophagitis
• Eradication of Helicobacter pylori (H. pylori) concurrently given with appropriate antibiotic therapy for treatment of H. pylori associated ulcers
• Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment
• Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk (see section 4.2) requiring continued therapy
• Symptomatic gastroesophageal reflux disease
• Zollinger-Ellison syndrome.

The divergences identified at the start of the referral were resolved.

The CHMP gave a positive opinion on 21 September 2006 recommending the harmonisation of the SPC, labelling and package leaflet for Agopton and associated names.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, labelling and package leaflet in Annex III.

A Decision was issued by the European Commission on 13 December 2006.

Summary information on referral opinion pursuant to Article 30 of Council Directive 2001/83/EC for Agopton and associated names (see Annex I) International Non-Proprietary Name (INN): Lansoprazole: Background information

AdoptedReference Number: EMEA/407636/2006

Key facts

About this medicine

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

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/407636/06
• Type:
  Article 30 referrals

  This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

Key dates and outcomes

• CHMP opinion date:
  21/09/2006
• EC decision date:
  13/12/2006

All documents

Agopton - Article 30 referral - Annex I, II, III

Adopted

Summary information on referral opinion pursuant to Article 30 of Council Directive 2001/83/EC for Agopton and associated names (see Annex I) International Non-Proprietary Name (INN): Lansoprazole: Background information

AdoptedReference Number: EMEA/407636/2006

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.