Porcilis PCV

RSS

adjuvanted inactivated vaccine against porcine circovirus

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 22/03/2017

Authorisation details

Product details
Name
Porcilis PCV
Agency product number
EMEA/V/C/000135
Active substance
porcine circovirus type 2 ORF2 subunit antigen
International non-proprietary name (INN) or common name
adjuvanted inactivated vaccine against porcine circovirus
Species
Pigs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI09AA07
Publication details
Marketing-authorisation holder
Intervet International BV
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
12/01/2009
Contact address
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

18/02/2017 Porcilis PCV - EMEA/V/C/000135 - IB/0010

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 for suidae

Therapeutic indication

For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to reduce weight loss associated with porcine-circovirus-type-2 infection occurring during the fattening period.

Onset of immunity: 2 weeks

Duration of immunity: 22 weeks

Assessment history

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