Cardoreg 4mg - referral

Current status

European Commission final decision

Overview

Cardoreg 4 mg prolonged release tablets and associated names (doxazosin) is a receptor alfa blocking agent used in the treatment of patients with essential hypertension and in the symptomatic treatment of patients with benign prostatic hyperplasia.

Pharmcom OY submitted applications for mutual recognition of Cardoreg 4 mg prolonged release tablets and associated names on the basis of the marketing authorisation granted by the Denmark on 30 September 2002. The Mutual Recognition Procedure started on 25 May 2005. The Reference Member State was Denmark and the Concerned Member States were: Czech Republic, Hungary, Poland, Slovakia, and 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 Denmark referred the reasons for disagreement to the EMEA on 3 March 2006.

The scope of the referral was to agree whether Cardoreg 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.

The arbitration procedure started on 23 March 2006. The CHMP appointed Dr. J.F.F. Lekkerkerker (Netherlands) as Rapporteur and Dr. Hudson (United Kingdom) as Co-rapporteur. The Marketing Authorisation Holder provided written explanations on 08 April 2006. Oral explanations were given by the Marketing Authorisation Holder on 27 June 2006.

During the June 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 Cardoreg 4 mg prolonged release tablets and associated names, that the objections raised 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 28 June 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 11/10/2006.

Opinion following an Article 29(2) referral for Cardoreg 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin: Background information

Adopted Reference Number: EMEA/CHMP/422351/2006

Key facts

About this medicine

• Approved name:
  Cardoreg 4mg
• International non-proprietary name (INN) or common name:
  doxazosin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/422351/06
• 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:
  28/06/2006
• EC decision date:
  11/10/2006

All documents

Cardoreg 4 mg - Article 29 referral - Annex I, II, III

Adopted

Opinion following an Article 29(2) referral for Cardoreg 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin: Background information

Adopted Reference Number: EMEA/CHMP/422351/2006

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.