Bayovac IBR Marker Vivum - referral

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.

Opinion following an Article-78 procedure for Bayovac IBR Marker Vivum and its associated names

Reference Number: EMA/308604/2014 Summary:

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.

Key facts

About this medicine

• 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

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/023b/001
• Type:
  Article 78 referrals (prior to January 2022)

  This type of referral is 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:
  21/01/2000
• EC decision date:
  10/07/2000

All documents

European Commission final decision

Bayovac IBR Marker Vivum Article-78 referral - Annex I, II, III

Opinion following an Article-78 procedure for Bayovac IBR Marker Vivum and its associated names

Reference Number: EMA/308604/2014 Summary:

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.

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)