Respiporc Flu3

RSS

inactivated influenza-A virus / swine

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 25/09/2017

Authorisation details

Product details
Name
Respiporc Flu3
Agency product number
EMEA/V/C/000153
Active substance
  • inactivated influenza-A virus
  • swine
International non-proprietary name (INN) or common name
inactivated influenza-A virus / swine
Species
Pigs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI09AA03
Publication details
Marketing-authorisation holder
IDT Biologika GmbH 
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
13/01/2010
Contact address
IDT Biologika GmbH
Am Pharmapark
PO Box 400 214
06861 Dessau-Rosslau
Germany

Product information

06/09/2017 Respiporc Flu3 - EMEA/V/C/000153 - II/0014

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

Active immunisation of pigs from the age of 56 days onwards, including pregnant sows, against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection.

Onset of immunity: 7 days after primary vaccination

Duration of immunity: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above.

Active immunisation of pregnant sows after finished primary immunisation by administration of a single dose 14 days prior to farrowing to develop high colostral immunity, which provides clinical protection of piglets for at least 33 days after birth.

Assessment history

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