Glimepirida Parke-Davis

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

Overview

On 19 July 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Glimepirida Parke-Davis (glimepiride, tablets 2, 3 and 4 mg). The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Glimepirida Parke-Davis outweigh its risks, and that the marketing authorisation can be granted in Portugal and in the following Member States of the EU: Cyprus, France, Germany, Italy, Sweden and the United Kingdom.

Key facts

Approved name
Glimepirida Parke-Davis
International non-proprietary name (INN) or common name
glimepiride
Associated names
  • Glimepiride Pfizer
  • Glimepirid Pfizer
  • Glimepiride tablets 2 mg
  • Glimepiride tablets 3 mg
  • Glimepiride tablets 4 mg
Class
Sulfonamides, urea derivatives
Reference number
EMEA/H/A-29/1338
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
19/07/2012
EC decision date
19/11/2012

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:

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