Hiprabovis IBR Marker Live

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live gene-deleted vaccine for intramuscular use for active immunisation of cattle against infectious bovine rhinotracheitis

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 06/07/2017

Authorisation details

Product details
Name
Hiprabovis IBR Marker Live
Agency product number
EMEA/V/C/000158
Active substance
live gE- tk- double-gene-deleted bovine herpes virus type 1, strain CEDDEL: 106.3–107.3 CCID50
International non-proprietary name (INN) or common name
live gene-deleted vaccine for intramuscular use for active immunisation of cattle against infectious bovine rhinotracheitis
Species
Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI02AD01
Publication details
Marketing-authorisation holder
Laboratorios Hipra S.A
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
27/01/2011
Contact address
Avda. La Selva 135
17170 Amer (Girona)
Spain

Product information

22/06/2017 Hiprabovis IBR Marker Live - EMEA/V/C/000158 - IG/0793

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

For the active immunisation of cattle from three months of age against bovine herpes virus type 1 (BoHV-1) to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.

Onset of immunity: 21 days after completion of the basic vaccination scheme.

Duration of immunity: 6 months after completion of the basic vaccination scheme

Assessment history

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