Ketabel 100 mg/ml solution for injection and associated names

Table of contents

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
Current status
European Commission final decision
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.
Authorisation model
Nationally authorised product(s)
Opinion date
05/12/2019
EC decision date
04/03/2020

All documents

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

  • Overview - lay-language summary of the stage of the procedure
  • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
  • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
  • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
  • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
  • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. veterinary healthcare professionals, farmers, academia) (if applicable)
  • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
  • Scientific conclusions – scientific conclusions of CVMP
  • Divergent positions – divergent positions of the CVMP members (if applicable)
  • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
  • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
  • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)

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