Solamocta 697 mg/g powder for use in drinking water for chickens, ducks and turkeys

Current status:
European Commission final decision

Overview

On 4 November 2015, 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 veterinary medicinal product Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the marketing authorisation for Solamocta can be granted provided that the recommended revised instructions on product administration and prudent use warnings are added to the product information.

Key facts

Approved name
Solamocta 697 mg/g powder for use in drinking water for chickens, ducks and turkeys
International non-proprietary name (INN) or common name
Amoxicillin (as trihydrate)
Class
-
Reference number
EMEA/V/A/112
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
04/11/2015
EC decision date
07/01/2016

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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