• Procedure started
  • Under evaluation
  • CVMP opinion
  • 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.

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.

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.

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.

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español (ES) (69.33 KB - PDF)

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čeština (CS) (70.03 KB - PDF)

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dansk (DA) (69.61 KB - PDF)

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Deutsch (DE) (70.54 KB - PDF)

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eesti keel (ET) (66.92 KB - PDF)

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ελληνικά (EL) (76.57 KB - PDF)

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français (FR) (69.3 KB - PDF)

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hrvatski (HR) (69.9 KB - PDF)

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italiano (IT) (68.05 KB - PDF)

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latviešu valoda (LV) (75.89 KB - PDF)

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lietuvių kalba (LT) (70.22 KB - PDF)

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magyar (HU) (69.76 KB - PDF)

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Malti (MT) (71.86 KB - PDF)

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Nederlands (NL) (69.49 KB - PDF)

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polski (PL) (70.4 KB - PDF)

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português (PT) (70.09 KB - PDF)

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română (RO) (69.73 KB - PDF)

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slovenčina (SK) (70.66 KB - PDF)

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slovenščina (SL) (68.85 KB - PDF)

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Suomi (FI) (67.03 KB - PDF)

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svenska (SV) (68.54 KB - PDF)

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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

български (BG) (218 KB - PDF)

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español (ES) (154.5 KB - PDF)

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čeština (CS) (195.94 KB - PDF)

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dansk (DA) (153.73 KB - PDF)

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Deutsch (DE) (160.18 KB - PDF)

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eesti keel (ET) (145.99 KB - PDF)

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ελληνικά (EL) (213.1 KB - PDF)

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français (FR) (156.11 KB - PDF)

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hrvatski (HR) (174.38 KB - PDF)

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íslenska (IS) (86.04 KB - PDF)

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italiano (IT) (151.16 KB - PDF)

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latviešu valoda (LV) (192.61 KB - PDF)

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lietuvių kalba (LT) (194.03 KB - PDF)

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magyar (HU) (201.07 KB - PDF)

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Malti (MT) (207.01 KB - PDF)

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Nederlands (NL) (151.31 KB - PDF)

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polski (PL) (190.71 KB - PDF)

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português (PT) (155.1 KB - PDF)

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română (RO) (189.34 KB - PDF)

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slovenčina (SK) (188.42 KB - PDF)

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slovenščina (SL) (176.4 KB - PDF)

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Suomi (FI) (143.87 KB - PDF)

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svenska (SV) (153.02 KB - PDF)

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български (BG) (75.51 KB - PDF)

View

español (ES) (69.33 KB - PDF)

View

čeština (CS) (70.03 KB - PDF)

View

dansk (DA) (69.61 KB - PDF)

View

Deutsch (DE) (70.54 KB - PDF)

View

eesti keel (ET) (66.92 KB - PDF)

View

ελληνικά (EL) (76.57 KB - PDF)

View

français (FR) (69.3 KB - PDF)

View

hrvatski (HR) (69.9 KB - PDF)

View

italiano (IT) (68.05 KB - PDF)

View

latviešu valoda (LV) (75.89 KB - PDF)

View

lietuvių kalba (LT) (70.22 KB - PDF)

View

magyar (HU) (69.76 KB - PDF)

View

Malti (MT) (71.86 KB - PDF)

View

Nederlands (NL) (69.49 KB - PDF)

View

polski (PL) (70.4 KB - PDF)

View

português (PT) (70.09 KB - PDF)

View

română (RO) (69.73 KB - PDF)

View

slovenčina (SK) (70.66 KB - PDF)

View

slovenščina (SL) (68.85 KB - PDF)

View

Suomi (FI) (67.03 KB - PDF)

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svenska (SV) (68.54 KB - PDF)

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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)

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