Amlovita - referral

Current status

European Commission final decision

Overview

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.

Opinion following an Article 29 referral Amlovita International Non-Proprietary Name (INN): Amlodipine: Background information and Annex I, II III

Adopted Reference Number: EMEA/CPMP/539/04

Key facts

About this medicine

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

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/CPMP/539/04
• 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:
  21/01/2004
• EC decision date:
  26/04/2004

All documents

Opinion following an Article 29 referral Amlovita International Non-Proprietary Name (INN): Amlodipine: Background information and Annex I, II III

Adopted Reference Number: EMEA/CPMP/539/04

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.