Suvaxyn Circo+MH RTU

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Porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)

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

Overview

This is a summary of the European public assessment report (EPAR) for Suvaxyn Circo+MH RTU.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 Suvaxyn Circo+MH RTU.

For practical information about using Suvaxyn Circo+MH RTU, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

This EPAR was last updated on 05/11/2018

Authorisation details

Product details
Name
Suvaxyn Circo+MH RTU
Agency product number
EMEA/V/C/003924
Active substance
Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein/Inactivated Mycoplasma hyopneumoniae, strain P-5722-3.
International non-proprietary name (INN) or common name
Porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)
Species
Pigs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI09AL
Publication details
Marketing-authorisation holder
Zoetis Belgium SA
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
05/11/2015
Contact address
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium

Product information

25/10/2018 Suvaxyn Circo+MH RTU - EMEA/V/C/003924 - IG/0976

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

  • inactivated viral and inactivated bacterial vaccines for pigs.

Therapeutic indication

For active immunisation of pigs from 3 weeks of age against porcine circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues and fecal shedding caused by infection with PCV2.

For active immunisation of pigs over the age of 3 weeks against Mycoplasma hyopneumoniae to reduce lung lesions caused by infection with M. hyopneumoniae.

Assessment history

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