Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli)

RSS

vaccine to provide passive immunity to the progeny against E. coli 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 14/04/2014

Authorisation details

Product details
Name
Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli)
Agency product number
EMEA/V/C/000024
Active substance
  • F4ab (K88ab) fimbrial adhesin
  • F4ac (K88ac) fimbrial adhesin
  • F5 (K99) fimbrial adhesin
  • F6 (987P) fimbrial adhesin
  • LT toxoid
International non-proprietary name (INN) or common name
vaccine to provide passive immunity to the progeny against E. coli in pigs
Species
Pigs (gilts and sows)
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI09AB02
Publication details
Marketing-authorisation holder
Intervet International BV
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
29/02/1996
Contact address
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

04/04/2014 Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli) - EMEA/V/C/000024 - IG/0420

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 immunisation of piglets by active immunisation of sows / gilts to reduce mortality and clinical signs such as diarrhoea due to neonatal enterotoxicosis during the first days of life, caused by those E.coli strains which express the fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P).

Assessment history

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