Carbamazepin Tillomed

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

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
  • Carbamazepin Tillomed
  • Carbamazepina Tillomed
  • Karbamazepin Tillomed
  • Karbamazepina Tillomed
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

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:

News

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