Ingelvac CircoFLEX

porcine circovirus type 2 ORF2 protein

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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.

What is Ingelvac CircoFLEX and what is it used for?

Ingelvac CircoFLEX is a vaccine used to protect pigs from the two weeks of age against porcine circovirus type 2 (PCV2). 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). Ingelvac CircoFLEX contains the active substance porcine circovirus type 2 ORF2 protein.

How is Ingelvac CircoFLEX used?

Ingelvac CircoFLEX is available as a suspension for injection and can only be obtained with a prescription. It is given by injection into the muscle as a single dose. The vaccine starts to be effective 2 weeks after vaccination and protection lasts for 17 weeks.

For further information, see the package leaflet.

How does Ingelvac CircoFLEX work?

Ingelvac CircoFLEX is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Ingelvac CircoFLEX contains small amounts of a protein from PCV2. When a pig is given the vaccine, the pig’s immune system recognises the protein as ‘foreign’ and reacts by building up an active immune response. In the future, the immune system will be able to react against the virus more quickly when it is exposed to the virus. This active immune response will help to protect the pig against the disease caused by this virus.

What benefits of Ingelvac CircoFLEX have been shown in studies?

Ingelvac CircoFLEX has been studied in a number of trials involving pigs of various breeds. These studies were performed under laboratory as well as under typical European farming conditions. The trials showed that vaccination of pigs with Ingelvac CircoFLEX reduced weight loss in the piglets. It also reduced the levels of PCV2 in the blood, clinical signs of PCV2 infection, the number of runts and death rates.

What are the risks associated with Ingelvac CircoFLEX?

The most common side effect with Ingelvac CircoFLEX (which may affect more than 1 in 10 animals) is a mild and short lived increase in body temperature on the day of vaccination.

For the full list of restrictions and all side effects reported with Ingelvac CircoFLEX, 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 Ingelvac CircoFLEX is ‘zero days’, which means there is no mandatory waiting time.

Why is Ingelvac CircoFLEX approved?

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

Other information about Ingelvac CircoFLEX:

The European Commission granted a marketing authorisation valid throughout the EU for Ingelvac CircoFLEX on 13 February 2008.

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

Name Language First published Last updated
Ingelvac CircoFLEX : EPAR - Summary for the public BG = bălgarski 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public ES = español 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public CS = čeština 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public DA = dansk 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public DE = Deutsch 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public ET = eesti keel 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public EL = elliniká 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public EN = English 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public FR = français 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public IT = italiano 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public LV = latviešu valoda 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public LT = lietuvių kalba 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public HU = magyar 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public MT = Malti 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public NL = Nederlands 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public PL = polski 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public PT = português 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public RO = română 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public SK = slovenčina 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public SL = slovenščina 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public FI = suomi 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public SV = svenska 2008-03-14 2017-07-21
Ingelvac CircoFLEX : EPAR - Summary for the public HR = Hrvatski 2008-03-14 2017-07-21

This EPAR was last updated on 07/09/2017 .

Authorisation details

Product details

Product details for Ingelvac CircoFLEX
NameIngelvac CircoFLEX
Agency product numberEMEA/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

Publication details for Ingelvac CircoFLEX
Marketing-authorisation holder

Boehringer Ingelheim Vetmedica GmbH

Revision13
Date of issue of marketing authorisation valid throughout the European Union13/02/2008

Contact address:

Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein
Germany

Product information

Product information

01/09/2017  Ingelvac CircoFLEX -EMEA/V/C/000126 -IG/0831

Name Language First published Last updated
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07
Ingelvac CircoFLEX : EPAR - Product Information HR = Hrvatski 2008-02-25 2017-09-07

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
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21
Ingelvac CircoFLEX : EPAR - All Authorised presentations HR = Hrvatski 2008-02-25 2011-11-21

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Ingelvac CircoFLEX : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2009-04-29 2017-09-07

Initial marketing-authorisation documents

Name Language First published Last updated
Ingelvac CircoFLEX : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2008-02-25  
Ingelvac CircoFLEX : EPAR - Scientific Discussion HR = Hrvatski 2008-02-25