Ketabel 100 mg/ml solution for injection and associated names

Current status:
European Commission final decision

Overview

On 5 December 2019, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Ketabel 100 mg/ml solution for injection and associated names (thereafter called Ketabel). The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ketabel outweigh its risks, and recommended that the marketing authorisation be granted in France and in all concerned Member States: Austria, Bulgaria, Czech Republic, Germany, Estonia, Greece, Finland, Hungary, Ireland, Iceland, Lithuania, Latvia, the Netherlands, Norway, Portugal, Romania, Sweden, Slovenia, Slovakia and the United Kingdom1.


1As of 1 February 2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period.

Key facts

Approved name
Ketabel 100 mg/ml solution for injection and associated names
International non-proprietary name (INN) or common name

Ketamine

Associated names
  • Ketabel vet. 100 mg/ml solution for injection
  • Belatamin 100 mg/ml solution for injection
  • Belatamin vet. 100 mg/ml solution for injection
Reference number
EMEA/V/A/133
Type
Article 33

Mutual-recognition and decentralised referral: initiated because of disagreement between Member States within the framework of the mutual-recognition or decentralised procedure.

Status
European Commission final decision
Opinion date
05/12/2019
EC decision date
04/03/2020

All documents

Document description

  • Opinion - contains the CVMP 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 may not always be available:

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