Doxazosin Retard "Arrow" 4 mg

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

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

Arrow Generics UK Ltd submitted applications for mutual recognition of Doxazosin Retard “Arrow” 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 21 October 2005. The Reference Member States were Portugal, Slovenia, 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 Denmark referred the reasons for disagreement to the EMEA on 31 March 2006.

The scope of the referral was to agree whether Doxazosin Retard “Arrow” 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 27 April 2006. The CHMP appointed Dr. J.F.F. Lekkerkerker (Netherlands) as Rapporteur and Dr. Hudson (United Kingdom) as Co-rapporteur. Supplementary information was provided by the Marketing Authorisation Holder on 23 May 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 Doxazosin Retard “Arrow” 4 mg prolonged release tablets and associated names, that the objections raised by 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.

Key facts

Approved name
Doxazosin Retard "Arrow" 4 mg
International non-proprietary name (INN) or common name

Doxazosin

Reference number
CHMP/423796/06
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.

Status
European Commission final decision
Opinion date
28/06/2006
EC decision date
11/10/2006

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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