Hiprabovis Pneumos - referral

Current status

European Commission final decision

Overview

Hiprabovis Pneumos Emulsion for injection for cattle is an inactivated vaccine for reduction of the clinical signs and lung lesions caused by Mannheimia haemolytica serotype A1 and Histophilus somni in calves from 2 months of age.

Due to concerns regarding reports of anaphylactic-type events following use of Hiprabovis Pneumos Emulsion for injection for cattle, France suspended the marketing authorisation for the product on 6 April 2011 triggering a procedure under Article 78 of Directive 2001/82/EC.

The procedure started on 5 May 2011. The rapporteur and co-rapporteur appointed were Dr Jean-Claude Rouby and Dr David Murphy, respectively. A written explanation was provided by the representative of the marketing authorisation holder on 23 May 2011.

Based on the rapporteurs' assessment of the data available from pharmacovigilance reports and a laboratory study, the CVMP concluded that the underlying cause of the adverse events observed has yet to be determined; the data evaluated indicated an association between vaccination of cattle with HIPRABOVIS PNEUMOS Emulsion for injection for cattle and the occurrence of anaphylactic-type events; no corrective measures could be recommended; and the benefit-risk balance for the product was unfavourable.

The Committee, adopted on 14 July 2011, an opinion recommending the suspension of the marketing authorisations for HIPRABOVIS PNEUMOS Emulsion for injection for cattle and associated names until the marketing authorisation holder proposes appropriate measures to mitigate the risk of occurrence of such adverse events and demonstrates a favourable benefit-risk balance for the product when used according to the recommendations of the summary of product characteristics

The list of product names concerned is given in Annex I. The scientific conclusions and grounds for suspension of the marketing authorisations are provided in Annex II.

The final opinion was converted into a Decision by the European Commission on 3 November 2011.

Opinion following an Article 78 procedure for Hiprabovis Pneumos emulsion for injection for cattle and associated names

AdoptedReference Number: EMA/CVMP/561772/2011Summary:

HIPRABOVIS PNEUMOS Emulsion for injection for cattle is an inactivated vaccine for reduction of the clinical signs and lung lesions caused by Mannheimia haemolytica serotype A1 and Histophilus somni in calves from 2 months of age.

Key facts

About this medicine

• Approved name:
  Hiprabovis Pneumos
• International non-proprietary name (INN) or common name:
  • Mannheimia haemolytica biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur.
  • inactivated Histophilus somni Bailie strain
• Class:
  -

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/072
• Type:
  Article 78

  Pharmacovigilance urgent measures: initiated when, as a result of the evaluation of veterinary pharmacovigilance data, a Member State considers that a marketing authorisation should be suspended, withdrawn or varied to restrict the indications or availability, amend the posology, add a contraindication or add a new precautionary measure.

Key dates and outcomes

• Opinion date:
  14/07/2011
• EC decision date:
  03/11/2011

All documents

Hiprabovis Pneumos emulsion - Article 78 referral - Annex I, II

Hiprabovis Pneumos - Article 78 referral - Divergent position

Opinion following an Article 78 procedure for Hiprabovis Pneumos emulsion for injection for cattle and associated names

AdoptedReference Number: EMA/CVMP/561772/2011Summary:

HIPRABOVIS PNEUMOS Emulsion for injection for cattle is an inactivated vaccine for reduction of the clinical signs and lung lesions caused by Mannheimia haemolytica serotype A1 and Histophilus somni in calves from 2 months of age.

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)