Bayovac IBR Marker Vivum

Current status:
European Commission final decision

Overview

Bayovac IBR Marker Vivum and its associated names are attenuated vaccines for active immunisation of cattle against the respiratory symptoms caused by Infectious Bovine Rhinotracheitis (IBR) virus.

Due to concerns regarding adverse events reports following use of Bayovac IBR Marker Vivum and its associated names, the United Kingdom suspended the marketing authorisation for the product on 16 March 1999, triggering a procedure under Article 23a of Council Directive 81/851/EEC, as amended.

The CVMP procedure under Article 23b of Directive 81/851/EEC started on 13 April 1999. The Committee appointed H. Lensing as rapporteur and M. Moos as co-rapporteur. Written explanations were provided by the marketing authorisation holders on 9 June 1999, 28 September 1999 and 21 December 1999. Oral explanations were given on 13 October 1999.

Based on the evaluation of the available data, the CVMP concluded that the marketing authorisations for Bayovac IBR Marker Vivum and its associated names should be amended. Therefore, the CVMP adopted a positive opinion on 21 January 2000, recommending variations to the terms of marketing authorisations for the above mentioned products.

The scientific conclusions are provided in Annex I. The list of product names concerned is given in Annex II, together with the Summaries of Product Characteristics in Annex III.

The final opinion was converted into a Decision by the European Commission on 10 July 2000.

Key facts

Approved name
Bayovac IBR Marker Vivum
International non-proprietary name (INN) or common name
bovine Herpes Virus type 1 (BHV-1), strain Difivac (IBR-Marker Virus, gE-negative), modified live (attenuated) virus
Associated names
  • Rhinobovin
  • Marker lebend
  • Rhinobovin Marker live
  • RhinobovinMarker Viva
  • Rhinobovin Marker Attenuato
  • Rhinobovin Marker Viva Marcada
Reference number
EMEA/V/A/023b/001
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of veterinary pharmacovigilance data, a Member State considers that a marketing authorisation should be suspended, withdrawn or varied to restrict the indications or availability, amend the posology, add a contraindication or add a new precautionary measure.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
21/01/2000
EC decision date
10/07/2000

All documents

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:

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