Hiprabovis Pneumos
Table of contents
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.
Key facts
| 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 |
-
|
| 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. |
| Status |
European Commission final decision
|
| Opinion date |
14/07/2011
|
| EC decision date |
03/11/2011
|
All documents
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List item
Opinion following an Article 78 procedure for Hiprabovis Pneumos emulsion for injection for cattle and associated names (PDF/65.85 KB)
Adopted
First published: 09/12/2011
Last updated: 09/12/2011
EMA/CVMP/561772/2011 -
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List item
Hiprabovis Pneumos emulsion - Article 78 referral - Annex I, II (PDF/68.53 KB)
First published: 09/12/2011
Last updated: 09/12/2011 -
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List item
Hiprabovis Pneumos - Article 78 referral - Divergent position (PDF/41.87 KB)
First published: 09/12/2011
Last updated: 09/12/2011
Document description
- Opinion - contains the CVMP opinion of the referred medicine(s)
- List of the medicines affected by the referral (Annex I)
- Scientific conclusions of the Committee (Annex II)
The following two documents may not always be available:
- Changes to the summary of product characteristics, labeling or package leaflet ('annex III') - available when changes have been recommended by the Committee
- Conditions of the marketing authorisation (Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies