Suvaxyn PCV

RSS

adjuvanted inactivated vaccine against porcine circovirus type 2 in piglets

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 05/11/2018

Authorisation details

Product details
Name
Suvaxyn PCV
Agency product number
EMEA/V/C/000149
Active substance
porcine circovirus recombinant virus (CPCV) 1-2, inactivated
International non-proprietary name (INN) or common name
adjuvanted inactivated vaccine against porcine circovirus type 2 in piglets
Species
Pigs (piglets)
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI09AA07
Publication details
Marketing-authorisation holder
Zoetis Belgium SA
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
23/07/2009
Contact address
Rue Laid Burnait, 1
1348 Louvain-la-Neuve
Belgium

Product information

25/11/2018 Suvaxyn PCV - EMEA/V/C/000149 - IG/0976 (0027)

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 over the age of three weeks against porcine circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues associated with PCV2 infection, as well as to reduce clinical signs - including loss of daily weight gain, and mortality associated with post-weaning multisystemic wasting syndrome.

Assessment history

News

How useful was this page?

Add your rating