Pantoprazole Olinka (EMEA/H/A-29/1170)
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Pantoprazole Olinka. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Pantoprazole Olinka outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the European Union, Germany and Poland.
The review was carried out under an 'Article 29' referral1.
1Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health.
Key facts
Approved name |
Pantoprazole Olinka (EMEA/H/A-29/1170)
|
International non-proprietary name (INN) or common name |
pantoprazole |
Associated names |
Pantecta
|
Reference number |
EMEA/H/A-29/1170
|
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 |
19/11/2009
|
EC decision date |
30/03/2010
|
All documents
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List item
Questions and answers on the referral for Pantoprazole Olinka pantoprazole 20 and 40 mg tablets (EMEA/H/A-29/1170) (PDF/96.3 KB)
Adopted
First published: 21/11/2009
Last updated: 09/03/2011
EMEA/CHMP/744722/2009 -
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List item
Pantoprazole Olinka (EMEA/H/A-29/1170) - Annex I, II, III, IV (PDF/148.52 KB)
First published: 08/03/2011
Last updated: 08/03/2011 -
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