Carbamazepin Tillomed
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
EMA recommends authorisation of Carbamazepin Tillomed (carbamazepine, 200 and 400 mg prolonged release tablets) in the EU
On 30 April 2020, the European Medicines Agency completed a review of Carbamazepin Tillomed and associated names following a disagreement among EU Member States regarding its authorisation. The Agency concluded that the benefits of Carbamazepin Tillomed outweigh its risks, and the marketing authorisation can be granted in Germany and the Member States of the EU where the company has applied for marketing authorisation (Croatia, Italy, Netherlands, Poland and Sweden), as well as in the United Kingdom.
Key facts
Approved name |
Carbamazepin Tillomed
|
International non-proprietary name (INN) or common name |
carbamazepin |
Associated names |
|
Reference number |
EMEA/H/A-29(4)/1497
|
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 |
30/04/2020
|
EC decision date |
25/06/2020
|
All documents
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Carbamazepin Tillomed Article 29(4) referral - EMA recommends authorisation of Carbamazepin Tillomed (carbamazepine, 200 and 400 mg prolonged release tablets) in the EU (PDF/110.02 KB)
First published: 30/04/2020
Last updated: 21/07/2020
EMA/388917/2020 -
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Carbamazepin Tillomed Article 29(4) referral - Annex I (PDF/72.56 KB)
First published: 21/07/2020 -
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Carbamazepin Tillomed Article 29(4) referral - Annex II (PDF/99.04 KB)
First published: 21/07/2020 -
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Carbamazepin Tillomed Article 29(4) referral - Annex III (PDF/64.76 KB)
First published: 30/04/2020
Last updated: 21/07/2020 -
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Carbamazepin Tillomed Article 29(4) referral - Assessment report (PDF/215.51 KB)
Adopted
First published: 03/07/2020
EMA/352448/2020
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