Denagard 45% - referral

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).

What is Denagard 45%?

Denagard 45% is a veterinary medicinal product available as granules for use in drinking water and contains 450 mg tiamulin hydrogen fumarate per gram product. Tiamulin is a semi-synthetic antibiotic belonging to the pleuromutilin group of antibiotics and works by inhibiting bacterial protein synthesis. Denagard 45% is indicated for the treatment of swine dysentery, colitis, ileitis, enzootic pneumonia and pleuropneumonia in pigs; chronic respiratory disease in chickens and infectious sinusitis and airsacculitis in turkeys.

Denagard 45% (and associated names such as Tiamutin 45%, Denagard 450 mg/g and Denagard vet 450 mg/g) is marketed in Austria, Belgium, Czech Republic, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Poland, Portugal, Romania, Slovak Republic and Spain.

Why was Denagard 45% reviewed?

Denagard 45% is authorised in the EU via national procedures. Germany noted that there are divergences across Member States in the way the veterinary medicinal product can be used, as seen in the differences in the product information in the countries where Denagard 45% is marketed.

On 24 August 2016, Germany referred the matter to the CVMP in order to harmonise the product information for Denagard 45% (and associated names) in the EU.

What are the conclusions of the CVMP?

Based on the evaluation of the currently-available data, the CVMP concluded that the product information for Denagard 45% and its associated names should be harmonised across the EU.

The amended product information is available on the 'All documents' tab.

The European Commission issued a decision on 14 July 2017.

Denagard 45% Article-34 referral - Questions and answers on Denagard 45% and its associated names

Reference Number: EMA/275123/2017Summary:

Outcome of a procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/114)

Key facts

About this medicine

• 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

About this procedure

• Current status:
  European Commission final decision
• 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.

Key dates and outcomes

• Opinion date:
  12/04/2017
• EC decision date:
  14/07/2017

All documents

European Commission final decision

Denagard 45% Article-34 referral - Annex I,II,III

Reference Number: EMEA/V/A/114

Denagard 45% Article-34 referral - Questions and answers on Denagard 45% and its associated names

Reference Number: EMA/275123/2017Summary:

Outcome of a procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/114)

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)