Coglapix suspension for injection for pigs - referral

Current status

European Commission final decision

Overview

On 3 June 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 medicine Coglapix suspension for injection for pigs. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Coglapix outweigh its risks, and the marketing authorisation granted in Hungary can be recognised in other Member States of the EU (see below). The product information for Coglapix in Hungary should also be amended.

What is Coglapix suspension for injection for pigs?

Coglapix is an inactivated bacterial vaccine against porcine actinobacillosis. The vaccine contains five formaldehyde-inactivated strains of Actinobacillus pleuropneumoniae. The vaccine is intended for active immunisation of pigs against pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2, in order to reduce the clinical signs and lung lesions associated with the disease.

Why was Coglapix suspension for injection for pigs reviewed?

Ceva-Phylaxia Veterinary Biologicals Co. Ltd. submitted an application for Coglapix for mutual recognition on the basis of the initial authorisation granted by Hungary. The company wanted the authorisation to be recognised in other EU Member States (the 'concerned Member States', in this instance Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden and the United Kingdom).

However, the Member States were not able to reach an agreement and the National Food Chain Safety Office of Hungary referred the matter to the CVMP for arbitration on 24 October 2014.

The grounds for the referral were concerns raised by Italy that the efficacy of Coglapix has not been adequately demonstrated, that the benefit of the vaccine under practical conditions of use has not been demonstrated and that the results obtained from duration of immunity studies were inconsistent.

What are the conclusions of the CVMP?

Based on the data presented it was concluded that following vaccination of pigs with Coglapix reduction of clinical signs and lung lesions associated with the disease has been demonstrated in laboratory efficacy studies, although some concerns on the statistical significance of the results still remain. Hence, the relevant sections of the Summary of Product Characteristics and package leaflet should be amended in order to reflect this. Duration of immunity was established for both serotypes (1 and 2) up to 16 weeks after vaccination according to the results of relevant challenge studies.

Therefore, based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that the benefits of Coglapix outweigh its risks, and recommended that the marketing authorisation be granted in all concerned Member States. The CVMP also recommended that the product information for the medicine in Hungary be amended.

The European Commission issued a decision on 28 August 2015.

Coglapix Article-33(4) referral - Questions and answers

Reference Number: EMEA/V/A/109Summary:

Questions and answers on Coglapix suspension for injection for pigs (inactivated porcine actinobacillosis vaccine) - Outcome of a procedure under Article 33(4) of Directive 2001/82/EC, as amended

Key facts

About this medicine

• Approved name:
  Coglapix suspension for injection for pigs
• International non-proprietary name (INN) or common name:
  inactivated porcine actinobacillosis vaccine

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/109
• 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.

Key dates and outcomes

• Opinion date:
  03/06/2015
• EC decision date:
  28/08/2015

All documents

European Commission final decision

Coglapix Article-33(4) referral - Annex I, II, III

Reference Number: EMEA/V/A/109

Coglapix Article-33(4) referral - Divergent position

Reference Number: EMEA/V/A/109

Coglapix Article-33(4) referral - Questions and answers

Reference Number: EMEA/V/A/109Summary:

Questions and answers on Coglapix suspension for injection for pigs (inactivated porcine actinobacillosis vaccine) - Outcome of a procedure under Article 33(4) of Directive 2001/82/EC, as amended

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)