- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Amlodipine is indicated for use in hypertension and stable angina pectoris.
The applicant submitted an application for mutual recognition of amlodipine maleate on the basis of the marketing authorisation granted by Sweden on 23 May 2003. The Application was submitted to Germany as a Concerned Member State. The dossier was submitted as abridged application according Article 10.1(a) (iii) of Directive 2001/83/EC, as amended, so called “generic application”. The Mutual Recognition Procedure started on 18 June 2003.
On 16 September 2003, Germany presented to the EMEA a referral under Article 29 of Directive 2001/83/EC, as amended. The referral by Germany mainly related to the fact that the incompatibility between lactose as an excipient in the chosen formulation and the active substance, as well as impurities in the active substance itself lead to avoidable impurities in the finished product.
The referral procedure started 25 September 2003. The Rapporteur and Co-Rapporteur appointed were: Dr J.L Robert and Dr F. Lekkerkerker , respectively. Written explanations were provided by the Marketing Authorisation Holder by 14 October 2003.
During its January 2004 meeting, the CPMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that although, the development of the product and the presence of avoidable impurities have raised important quality concerns, there appears to be no safety concerns arising from the impurity profile in this product, based on the toxicology studies provided by the company. The Benefit/Risk ratio of the product is still favourable and remains unchanged at the end of the arbitration procedure. A positive opinion was adopted on 20 January 2004. At the time of the CPMP opinion a minor quality concern remained, having no impact in the benefit/risk balance of the product. Therefore, the CPMP recommended that this should be dealt with as conditions and should not pose a barrier to a positive opinion. Since the SPC was not a dispute, and no changes were proposed arising from the arbitration process, the latest agreed Summary of Product Characteristics of the Reference Member State remains unchanged.
The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the Summary of Product Characteristics in the Annex III.
The final opinion was converted into a Decision by the European Commission on 26 April 2004.
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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.
European Commission final decision
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Opinion following an Article 29 referral Amlovita International Non-Proprietary Name (INN): Amlodipine: Background information and Annex I, II III (PDF/197.97 KB)Adopted
First published: 26/04/2004
Last updated: 26/04/2004
- 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