Denagard 45%

Current status:
European Commission final decision


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
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.

European Commission final decision
Opinion date
EC decision date

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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