Suvaxyn PRRS MLV

Modified live porcine respiratory and reproductive syndrome virus

  • Email
  • Help

About

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

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

What is Suvaxyn PRRS MLV and what is it used for?

Suvaxyn PRRS MLV is a veterinary vaccine used to protect pigs against porcine respiratory and reproductive syndrome (PRRS). This viral disease of pigs may result in lowered farrowing (birth) rates, increase in abortions, stillborn, mummified as well as weak live born piglets and deaths. There may also be disease of the airways which can lead to high death rates in suckling and weaned pigs.

Suvaxyn PRRS MLV contains a modified strain of live PRRS virus, strain 96V198, that has been weakened so that it does not cause disease.

How is Suvaxyn PRRS MLV used?

Suvaxyn PRRS MLV is available as lyophilisate (a freeze-dried pellet) and solvent to make a suspension for injection and can only be obtained with a prescription. Suvaxyn PRRS MLV is given as a single injection from 1 day of age to pigs for fattening. Gilts (female pigs that have not yet had piglets) and sows (female pigs that have had piglets) are given a single injection before introduction into the herd, about 4 weeks before breeding, and a booster injection every 4 months. Mass vaccination can take place in herds in which presence of European PRRS virus is known. Protection starts to be effective 28 days after vaccination and lasts for 26 weeks after vaccination in fattening pigs and 16 weeks after vaccination in gilts and sows.

For further information, see the package leaflet.

How does Suvaxyn PRRS MLV work?

Suvaxyn PRRS MLV is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Suvaxyn PRRS MLV contains a weakened strain of PRRS virus. When a pig is given the vaccine, the pig’s immune system recognises the virus as ‘foreign’ and makes antibodies against it. In the future, the immune system will be able to react against the virus more quickly. This will help protect the pig against the disease.

What benefits of Suvaxyn PRRS MLV have been shown in studies?

The effectiveness of Suvaxyn PRRS MLV was supported by laboratory studies. Two studies in piglets showed the vaccine starts to be effective 28 days after vaccination and four studies in piglets showed protection lasts up to 26 weeks. Two studies were conducted in female pigs, one which showed that single vaccination of female pigs 4 to 11 weeks before mating protected them against diseases when exposed to the virus in late pregnancy. The protection lasted 16 weeks. The second study in gilts showed that a booster vaccination 4 months after the initial vaccination, with mating performed 4 to 5 weeks after the second vaccination gave protection in the second half of pregnancy.

What are the risks associated with Suvaxyn PRRS MLV?

The most common side effects with Suvaxyn PRRS MLV (which may affect more than 1 in 10 pigs) are a short lived increase in body temperature (0.5 °C on average) within 4 days of vaccination and in sows local reactions in the form of swellings which resolve without treatment in 5 to 9 days.

For the full list of all side effects reported with Suvaxyn PRRS MLV, 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 PRRS MLV is ‘zero’ days, which means there is no mandatory waiting time.

Why is Suvaxyn PRRS MLV approved?

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

Other information about Suvaxyn PRRS MLV

The European Commission granted a marketing authorisation valid throughout the EU for Suvaxyn PRRS MLV on 24 August 2017.

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

Name Language First published Last updated
Suvaxyn PRRS MLV : EPAR - Summary for the public BG = bălgarski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public ES = español 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public CS = čeština 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public DA = dansk 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public DE = Deutsch 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public ET = eesti keel 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public EL = elliniká 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public EN = English 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public FR = français 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public IT = italiano 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public LV = latviešu valoda 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public LT = lietuvių kalba 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public HU = magyar 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public MT = Malti 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public NL = Nederlands 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public PL = polski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public PT = português 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public RO = română 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public SK = slovenčina 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public SL = slovenščina 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public FI = suomi 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public SV = svenska 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Summary for the public HR = Hrvatski 2017-09-21  

This EPAR was last updated on 21/09/2017 .

Authorisation details

Product details

Product details for Suvaxyn PRRS MLV
NameSuvaxyn PRRS MLV
Agency product numberEMEA/V/C/004276
Active substance

Modified live porcine respiratory and reproductive syndrome virus

International non-proprietary name (INN) or common name

Porcine respiratory and reproductive syndrome virus vaccine (live)

Species Pigs
Anatomical therapeutic chemical veterinary (ATCvet) codes QI09AD03





Publication details

Publication details for Suvaxyn PRRS MLV
Marketing-authorisation holder

Zoetis Belgium SA

Revision0
Date of issue of marketing authorisation valid throughout the European Union24/08/2017

Contact address:

Zoetis Belgium SA
Rue Laid Burniat, 1 
1348 Louvain-la-Neuve 
Belgium

Product information

Product information

24/08/2017  Suvaxyn PRRS MLV -EMEA/V/C/004276

Name Language First published Last updated
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - Product Information HR = Hrvatski 2017-09-21  

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 PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  
Suvaxyn PRRS MLV : EPAR - All Authorised presentations HR = Hrvatski 2017-09-21  

Pharmacotherapeutic group

Immunologicals for Suidae, live viral vaccines

Therapeutic indication

For active immunisation of clinically healthy pigs from 1 day of age in a porcine respiratory and reproductive syndrome (PRRS) virus contaminated environment, to reduce viraemia and nasal shedding caused by infection with European strains of PRRS virus (genotype 1).

Fattening pigs: In addition, vaccination of seronegative 1-day-old piglets was demonstrated to significantly reduce lung lesions against challenge administered at 26 weeks post vaccination. Vaccination of seronegative 2-week-old piglets was demonstrated to significantly reduce lung lesions and oral shedding against challenge administered at 28 days and at 16 weeks post-vaccination.

Gilts and sows: In addition, pre-pregnancy vaccination of clinically healthy gilts and sows, either seropositive or seronegative, was demonstrated to reduce the transplacental infection caused by PRRS virus during the third trimester of pregnancy, and to reduce the associated negative impact on reproductive performance (reduction of the occurrence of stillbirths, of piglet viraemia at birth and at weaning, of lung lesions and of viral load in lungs in piglets at weaning).

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 PRRS MLV : EPAR - Public assessment report HR = Hrvatski 2017-09-21  
CVMP summary of positive opinion for Suvaxyn PRRS MLV HR = Hrvatski 2017-06-16  

Authorised

This medicine is approved for use in the European Union