Rhiniseng

RSS

inactivated vaccine to prevent progressive and non-progressive atrophic rhinitis in pigs

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 14/07/2017

Authorisation details

Product details
Name
Rhiniseng
Agency product number
EMEA/V/C/000160
Active substance
  • inactivated Bordetella bronchiseptica, strain 833CER
  • recombinant type-D Pasteurella-multocida toxin (PMTr)
International non-proprietary name (INN) or common name
inactivated vaccine to prevent progressive and non-progressive atrophic rhinitis in pigs
Species
Pigs (gilts and sows)
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI09AB04
Publication details
Marketing-authorisation holder
Laboratorios Hipra S.A.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
16/09/2010
Contact address
Avda. La Selva, 135
17170- Amer (Girona)
Spain

Product information

22/06/2017 Rhiniseng - EMEA/V/C/000160 - 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 passive protection of piglets via colostrum after active immunisation of sows and gilts to reduce the clinical signs and lesions of progressive and non-progressive atrophic rhinitis, as well as to reduce weight loss associated with Bordetella-bronchiseptica and Pasteurella-multocida infections during the fattening period.

Challenge studies have demonstrated that passive immunity lasts until piglets are six weeks of age while in clinical field trials, the beneficial effects of vaccination (reduction in nasal lesion score and weight loss) are observed until slaughter.

Assessment history

How useful was this page?

Add your rating