Lisonorm - referral

Current status

European Commission final decision

Overview

Lisonorm tablet contains 5mg amlodipine/ 10mg lisinopril and is an anti-hypertensive indicated in patients with blood pressure adequately controlled with lisinopril and amlodipine given concurrently at the same dose level.

Gedeon Richter Plc obtained a national marketing authorisation for Lisonorm which was authorised in Bulgaria on 29 December 2006, before Bulgaria joined the European Union.

Gedeon Richter Plc submitted a Marketing Authorisation Application (MAA) via mutual recognition procedure for Lisonorm on the basis of the marketing authorisation granted by Hungary on 30 April 2004. The Mutual Recognition Procedure started on 3 August 2007.

The Reference Member State was Hungary and the Concerned Member States were Czech Republic, Estonia, Hungary, Lithuania, Latvia, Poland, Romania and Slovak Republic. 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 and Latvia referred the reasons for disagreement to the EMEA on 1 February 2008. Concerns related to the formal proof of bioequivalence and the lack of a wide therapeutic experience which were considered a potential serious risk to public health.

The arbitration procedure started on 21 February 2008 with the adoption of a list of questions. The Rapporteur was Dr Ondřej Slanař (CZ) and Co-Rapporteur(s) was Prof János Borvendég (HU). The Marketing Authorisation Holder provided written explanations on 2 June 2008.

During their July 2008 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 Lisonorm, that the objections raised by Czech Republic and Latvia should not prevent the granting of a Marketing Authorisation. 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 24 July 2008.

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 12 November 2008.

Opinion following an Article 29(4) referral for Lisonorm and associated names International Non-Proprietary Name (INN): lisinopril + amlodipine: Background information

Adopted Reference Number: EMEA/CHMP/633842/2008

Key facts

About this medicine

• Approved name:
  Lisonorm
• International non-proprietary name (INN) or common name:
  • lisinopril
  • amlodipine

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/633842/2008
• 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:
  25/07/2008
• EC decision date:
  12/11/2008

All documents

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

Adopted

Opinion following an Article 29(4) referral for Lisonorm and associated names International Non-Proprietary Name (INN): lisinopril + amlodipine: Background information

Adopted Reference Number: EMEA/CHMP/633842/2008

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.