Nifedipine Pharmamatch 30 and 60 mg - referral

Current status

European Commission final decision

Overview

Nifedipine Pharmamatch 30 and 60 mg prolonged release tablets (nifedipine) is 1,4 – dihydropyridine calcium antagonist used for symptomatic treatment of chronic stable angina pectoris as monotherapy or in combination with a beta-blocker and in the treatment of patients with light to moderate essential hypertension.

Pharmamatch BV submitted applications for mutual recognition of Nifedipine Pharmamatch retard 30 and 60 mg tablets on the basis of the marketing authorisation granted by the Netherlands on 29 November 2004. The Mutual Recognition Procedure started on 25 May 2005. The Reference Member State was Netherlands and the Concerned Member States were Belgium and the United Kingdom.

These Member States were not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State. The United Kingdom referred the reasons for disagreement to the EMEA on 23 August 2005.

Significant differences have been identified with regard to the proposed SPC compared to the SPC of the reference product in the UK. The differences in section 4.3 and 4.6 were considered to be of serious public health concern. Section 4.3 and 4.6 of the SPC of the reference product in the UK contains the information that the product is contraindicated in pregnancy, for women capable of childbearing or for nursing mothers.

The arbitration procedure started on 15 September 2005. The Rapporteur and Co-Rapporteur appointed were Tomas Salmonson and Eric Abadie, respectively. The Marketing Authorisation Holder provided written explanations on 13 October 2005.

During the January 2006 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 Nifedipine Pharmamatch retard 30 and 60 mg tablets, that the objections raised by United Kingdom should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended. A positive opinion was adopted 26 January 2006.

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 03 April 2006.

Opinion following an Article 29(2) referral for Nifedipine Pharmamatch 30 and 60 mg International Non-Proprietary Name (INN): Nifedipine: Background information

AdoptedReference Number: EMEA/CHMP/106563/2006

Key facts

About this medicine

• Approved name:
  Nifedipine Pharmamatch 30 and 60 mg
• International non-proprietary name (INN) or common name:
  nifedipine

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/106563/06
• 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:
  27/01/2006
• EC decision date:
  03/04/2006

All documents

Nifedipine Pharmamatch 30 and 60 mg - Article 29 referral - Annex I, II, III

Adopted

Opinion following an Article 29(2) referral for Nifedipine Pharmamatch 30 and 60 mg International Non-Proprietary Name (INN): Nifedipine: Background information

AdoptedReference Number: EMEA/CHMP/106563/2006

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.