Denagard 45%

Current status:
European Commission final decision

Overview

On 12 April 2017, the European Medicines Agency (the Agency) completed a review of Denagard 45%. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that there is a need to harmonise the product information (summary of product characteristics (SPC), labelling and package leaflet) for Denagard 45% in the European Union (EU).

Key facts

Approved name
Denagard 45%
International non-proprietary name (INN) or common name
Tiamulin hydrogen fumarate
Associated names
  • Tiamutin 45%
  • Denagard 450 mg/g
  • Denagard vet 450 mg/g
Reference number
EMEA/V/A/114
Type
Article 34

Divergent decision referral: initiated in order to obtain harmonisation within the EU of the conditions of authorisation for products already authorised by Member States.

Status
European Commission final decision
Opinion date
12/04/2017
EC decision date
14/07/2017

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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