Ingelvac CircoFLEX

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inactivated porcine circovirus vaccine

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

Overview

This is a summary of the European public assessment report (EPAR) for Ingelvac CircoFLEX.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 Ingelvac CircoFLEX.

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

This EPAR was last updated on 30/11/2017

Authorisation details

Product details
Name
Ingelvac CircoFLEX
Agency product number
EMEA/V/C/000126
Active substance
porcine circovirus type 2 ORF2 protein
International non-proprietary name (INN) or common name
inactivated porcine circovirus vaccine
Species
Pigs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI09AA07
Publication details
Marketing-authorisation holder
Boehringer Ingelheim Vetmedica GmbH
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
12/02/2008
Contact address
D-55216 Ingelheim am Rhein
Germany

Product information

23/11/2017 Ingelvac CircoFLEX - EMEA/V/C/000126 - IG/0855/G

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 active immunisation of pigs over the age of two weeks against porcine circovirus type 2 (PCV2) to reduce mortality, clinical signs - including weight loss - and lesions in lymphoid tissues associated with PCV2-related disease (PCVD).

In addition, vaccination has been shown to reduce PCV2 nasal shedding, viral load in blood and lymphoid tissues, and duration of viraemia.

Onset of protection occurs as early as two weeks post vaccination and lasts for at least 17 weeks.

Assessment history

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