Glimepirida Parke-Davis
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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 |
|
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
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Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) (PDF/57 KB)
First published: 20/07/2012
Last updated: 06/12/2012
EMA/480596/2012, Rev. 1 -
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Glimepirida Parke Davis - Article 29(4) referral - Assessment report (PDF/135.39 KB)
First published: 06/12/2012
Last updated: 06/12/2012 -
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Glimepirida Parke Davis - Article 29(4) referral - Annex I (PDF/60.06 KB)
First published: 06/12/2012
Last updated: 06/12/2012 -
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Glimepirida Parke Davis - Article 29(4) referral - Annex II (PDF/46.78 KB)
First published: 06/12/2012
Last updated: 06/12/2012 -
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Glimepirida Parke Davis - Article 29(4) referral - Annex III (PDF/16.43 KB)
First published: 06/12/2012
Last updated: 06/12/2012 -
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