Dexadreson - referral

Current status

European Commission final decision

Overview

The veterinary medicinal products Dexadreson 2 mg/ml and its associated names and generic products thereof are solutions for injection which contain 2 mg dexamethasone per ml. Dexamethasone is a long acting synthetic glucocorticoid used as anti-inflammatory, antiallergic and gluconeogenetic agent for administration to agricultural and domestic animals.

On 22 August 2012, Germany presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding Dexadreson 2 mg/ml and associated names, and generic products thereof. The CVMP was requested to evaluate the adequacy and consumer safety of the withdrawal periods for meat in cattle and horses and the withdrawal periods for milk in cattle for the concerned products.

The referral started on 12 September 2012. The Committee appointed Dr C. Ibrahim as rapporteur and Dr D. Murphy as co-rapporteur. Written explanations were provided by the marketing authorisation holders on 10 December 2012and 21 May 2013.

Based on the evaluation of the currently available data, the CVMP considered that overall benefit-risk profile for these products remains positive subject to changes of the product information related to harmonisation of the withdrawal periods. Therefore, the Committeeadopted a positive opinion on 18 July 2013, recommending variations to the terms of the marketing authorisations for Dexadreson 2 mg/ml and its associated names and generic products thereof.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.

The final opinion was converted into a Decision by the European Commission on 18 October 2013.

Opinion following an Article 35 referral for Dexadreson 2 mg/ml and associated names, and generic products thereof

AdoptedReference Number: EMA/539466/2013

Key facts

About this medicine

• Approved name:
  Dexadreson
• International non-proprietary name (INN) or common name:
  dexamethasone

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/087
• Type:
  Article 35

  Community interest referral: initiated in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment.

Key dates and outcomes

• Opinion date:
  18/07/2013
• EC decision date:
  18/10/2013

All documents

European Commission final decision

Dexadreson - Article-35 referral - Annexes I, II, III

Opinion following an Article 35 referral for Dexadreson 2 mg/ml and associated names, and generic products thereof

AdoptedReference Number: EMA/539466/2013

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)