Ketabel 100 mg/ml solution for injection and associated names
Table of contents
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 |
|
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
-
List item
Questions and answers on Ketabel 100 mg/ml solution for injection and associated names (ketamine) (PDF/113.92 KB)
First published: 16/04/2020
EMA/77090/2020 -
-
List item
Ketabel Article-33(4) referral - Annex I, II, III (PDF/198.28 KB)
Adopted
First published: 16/04/2020 -
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:
- Changes to the summary of product characteristics, labeling or package leaflet ('annex III') - available when changes have been recommended by the Committee
- Conditions of the marketing authorisation (Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies