Suvaxyn Circo

porcine circovirus vaccine (inactivated, recombinant)

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

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

What is Suvaxyn Circo and what is it used for?

Suvaxyn Circo is a veterinary vaccine used to protect pigs over the age of 3 weeks against porcine circovirus type 2 (PCV2). Infections can produce clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty breathing, pale skin and jaundice (yellowing of the skin).

Suvaxyn Circo contains an inactivated (killed) active substance derived from porcine circovirus type 2.

How is Suvaxyn Circo used?

Suvaxyn Circo, which is available as a liquid for injection, is given to pigs from three weeks of age as a single injection into the muscle in the neck behind the ear. Protection starts three weeks after vaccination and lasts for 23 weeks after vaccination. Suvaxyn Circo is only available on prescription.

For further information, see the package leaflet.

How does Suvaxyn Circo work?

Suvaxyn Circo is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. The vaccine contains small amounts of a protein from PCV2 that have been killed (inactivated) so that they do not cause disease. When Suvaxyn Circo is given to pigs the animals’ immune system recognises the viral protein as ‘foreign’ and makes antibodies against it. In the future, if the animals come into contact with the virus the immune system will be able to respond quickly to destroy the virus. This will help protect the pigs against porcine circovirus infections.

Suvaxyn Circo also contains adjuvants (ingredients that strengthen the immune response) called squalane, poloxamer 401 and polysorbate 80.

What benefits of Suvaxyn Circo have been shown in studies?

The studies on the effectiveness of Suvaxyn Circo were carried out with a similar vaccine, Suvaxyn Circo+MH RTU, which contains PCV2 and the bacteria Mycoplasma hyopneumoniae. Suvaxyn Circo+MH RTU is already approved in the EU.

The effectiveness of Suvaxyn Circo+MH RTU was first studied in several laboratory studies in pigs. The purpose of these studies was to establish how long it took pigs to be fully protected and how long the protection against PCV2 lasted. The studies showed that the vaccine had its full effect against PCV2 by three weeks after vaccination. Protection lasted 23 weeks after vaccination for PCV2.

The effectiveness of Suvaxyn Circo+MH RTU against PCV2 infection was also studied in three field studies. The field studies showed that Suvaxyn Circo reduced the PCV2 viraemia (presence of virus in the blood) compared to pigs given dummy vaccination.

What are the risks associated with Suvaxyn Circo?

The most common side effects with Suvaxyn Circo (which may affect more than 1 in 10 animals) are a short-lived increase in body temperature during the first 24 hours after vaccination and swelling (generally no wider than 2 cm) at the injection site which may last for up to 2 days.

For the full list of restrictions and side effects with Suvaxyn Circo, see the package leaflet.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

No special precautions are required.

What is the withdrawal period in food-producing animals?

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.

The withdrawal period for meat from pigs treated with Suvaxyn Circo is ‘zero’ days, which means there is no mandatory waiting time.

Why is Suvaxyn Circo approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Suvaxyn Circo’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Suvaxyn Circo

The European Commission granted a marketing authorisation valid throughout the EU for Suvaxyn Circo on 7 February 2018.

The full EPAR for Suvaxyn Circo can be found on the Agency’s website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. For more information about treatment with Suvaxyn Circo, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Suvaxyn Circo : EPAR - Summary for the public BG = bălgarski 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public ES = español 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public CS = čeština 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public DA = dansk 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public DE = Deutsch 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public ET = eesti keel 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public EL = elliniká 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public EN = English 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public FR = français 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public IT = italiano 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public LV = latviešu valoda 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public LT = lietuvių kalba 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public HU = magyar 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public MT = Malti 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public NL = Nederlands 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public PL = polski 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public PT = português 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public RO = română 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public SK = slovenčina 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public SL = slovenščina 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public FI = suomi 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public SV = svenska 2018-04-20  
Suvaxyn Circo : EPAR - Summary for the public HR = Hrvatski 2018-04-20  

This EPAR was last updated on 20/04/2018 .

Authorisation details

Product details

Product details for Suvaxyn Circo
NameSuvaxyn Circo
Agency product numberEMEA/V/C/004242
Active substance

porcine circovirus vaccine (inactivated, recombinant)

International non-proprietary name (INN) or common name

porcine circovirus vaccine (inactivated, recombinant)

Species
Anatomical therapeutic chemical veterinary (ATCvet) codes QI09AA07


Publication details

Publication details for Suvaxyn Circo
Marketing-authorisation holder

Zoetis Belgium SA

Revision0
Date of issue of marketing authorisation valid throughout the European Union07/02/2018

Contact address:

Rue Laid Burniat 
1 1348 Louvain-la-Neuve 
Belgium

Product information

Product information

07/02/2018  Suvaxyn Circo -EMEA/V/C/004242

Name Language First published Last updated
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - Product Information HR = Hrvatski 2018-04-20  

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.


Name Language First published Last updated
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  
Suvaxyn Circo : EPAR - All Authorised presentations HR = Hrvatski 2018-04-20  

Pharmacotherapeutic group

Immunologicals for suidae, inactivated viral 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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Suvaxyn Circo : EPAR - Public assessment report HR = Hrvatski 2018-04-20  
CVMP summary of positive opinion for Suvaxyn Circo HR = Hrvatski 2017-12-08  

Authorised

This medicine is approved for use in the European Union