Circovac

RSS

adjuvanted inactivated vaccine against porcine circovirus type 2

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Circovac. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Circovac.

For practical information about using Circovac, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

This EPAR was last updated on 19/09/2017

Authorisation details

Product details
Name
Circovac
Agency product number
EMEA/V/C/000114
Active substance
inactivated porcine circovirus type 2 (PCV2)
International non-proprietary name (INN) or common name
adjuvanted inactivated vaccine against porcine circovirus type 2
Species
Pigs (gilts and sows)
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI09AA07
Publication details
Marketing-authorisation holder
CEVA-Phylaxia Oltóanyagtermelõ Zrt.
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
21/06/2007
Contact address
Szállás u. 5.
1107 Budapest
Hungary

Product information

13/06/2017 Circovac - EMEA/V/C/000114 - T/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 FOR SUIDAE

Therapeutic indication

Sows and gilts

Passive immunisation of piglets via the colostrum, after active immunisation of sows and gilts, to reduce lesions in lymphoid tissues associated with PCV2 infection and as an aid to reduce PCV2-linked mortality.

Piglets

Active immunisation of piglets to reduce faecal excretion of PCV2 and virus load in blood, and as an aid to reduce PCV2-linked clinical signs, including wasting, weight loss and mortality, as well as to reduce virus load and lesions in lymphoid tissues associated with PCV2 infection.

Assessment history

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