Lisonorm

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
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.

Key facts

Approved name
Lisonorm
International non-proprietary name (INN) or common name
lisinopril + amlodipine
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.

Status
European Commission final decision
Opinion date
25/07/2008
EC decision date
12/11/2008

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

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