MS-H Vaccine

Mycoplasma synoviae strain MS-H

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This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is MS-H Vaccine?

MS-H Vaccine is a vaccine that contains a strain of the bacterium Mycoplasma synoviae called MS-H. It is available as eye drops.

What is MS-H Vaccine used for?

MS-H Vaccine is used in chickens from five weeks of age to protect them against Mycoplasma synoviae. This bacterium causes infections in birds, generally in the lungs and the ‘air sacs’, the specialised bags within the bird’s body where air is stored during breathing. Infection with Mycoplasma synoviae is also associated with poor quality of the eggshell. MS-H Vaccine is used in young chickens bred to be broilers (for meat) and layers (for egg production) to reduce the damage to airs sacs and reduce the number of eggs with abnormal shells.

MS-H Vaccine is given as one eye drop into one eye. The whole flock should be vaccinated at the same time.

How does MS-H Vaccine work?

MS-H vaccine contains a live, attenuated strain of Mycoplasma synoviae. ‘Attenuated’ means that the strain has first been weakened so that it does not cause disease.

MS-H Vaccine, like all vaccines, works by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. When MS-H Vaccine is given to chickens the immune system recognises the weakened strain as ‘foreign’ and makes defences against it. In the future, if the animals are exposed to Mycoplasma synoviae, the immune system will be able to respond more quickly. This will help to protect against the disease.

How has MS-H Vaccine been studied?

The company presented data from laboratory studies and from one field trial. The laboratory studies included a challenge model of Mycoplasma synoviae infection as well as a study looking at the effect of vaccination on eggshell abnormalities. The field study looked at how vaccinated chickens fared when moved to flocks with a history of Mycoplasma synoviae infection.

What benefit has MS-H Vaccine shown during the studies?

The laboratory studies showed that MS-H Vaccine reduces damage to the air sacs and reduces the number of eggs with shell abnormalities. The field study did not bring additional information.

What is the risk associated with MS-H Vaccine?

The vaccine has no known side effects.

It should not be used in birds in lay or within five weeks of the start of the laying period.

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

Any accidental splashing to the face and eyes should be thoroughly washed with water.

What is the withdrawal period?

The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption. The withdrawal period for MS-H Vaccine for meat and eggs is zero days.

Why has MS-H Vaccine been approved?

The CVMP concluded that the benefits of MS-H Vaccine outweigh the risks for the active immunisation of future broiler breeder chickens, future layer breeder chickens and future layer chickens to reduce air sac lesions and reduce the number of eggs with abnormal shell formation caused by Mycoplasma synoviae, and recommended that MS-H Vaccine be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about MS-H Vaccine:

The European Commission granted a marketing authorisation valid throughout the European Union, for MS-H vaccine to Pharmsure Ltd on 14 June 2011. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
MS-H Vaccine : EPAR - Summary for the public BG = bălgarski 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public ES = español 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public CS = čeština 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public DA = dansk 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public DE = Deutsch 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public ET = eesti keel 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public EL = elliniká 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public EN = English 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public FR = français 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public IT = italiano 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public LV = latviešu valoda 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public LT = lietuvių kalba 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public HU = magyar 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public MT = Malti 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public NL = Nederlands 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public PL = polski 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public PT = português 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public RO = română 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public SK = slovenčina 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public SL = slovenščina 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public FI = suomi 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public SV = svenska 2011-07-08 2016-09-29
MS-H Vaccine : EPAR - Summary for the public HR = Hrvatski 2011-07-08 2016-09-29

This EPAR was last updated on 29/09/2016 .

Authorisation details

Product details

Product details for MS-H Vaccine
NameMS-H Vaccine
Agency product numberEMEA/V/C/000161
Active substance

Mycoplasma synoviae strain MS-H

International non-proprietary name (INN) or common name

Mycoplasma synoviae strain MS-H

Species Chicken
Anatomical therapeutic chemical veterinary (ATCvet) codeQI01AE03

Publication details

Publication details for MS-H Vaccine
Marketing-authorisation holder

Pharmsure Ltd

Revision3
Date of issue of marketing authorisation valid throughout the European Union14/06/2011

Contact address:

Pharmsure Ltd
Bewell House
Bewell Street
Hereford
HR4 0BA
United Kingdom

Product information

Product information

17/05/2016  MS-H Vaccine -EMEA/V/C/000161 -R/009

Name Language First published Last updated
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25
MS-H Vaccine : EPAR - Product Information HR = Hrvatski 2011-07-08 2016-05-25

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
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  
MS-H Vaccine : EPAR - All Authorised presentations HR = Hrvatski 2011-07-08  

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

For active immunisation of future broiler breeder chickens, future layer breeder chickens and future layer chickens to reduce air sac lesions and reduce the number of eggs with abnormal shell formation caused by Mycoplasma synoviae.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
MS-H Vaccine : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2014-04-16 2016-05-25

Initial marketing-authorisation documents

Name Language First published Last updated
MS-H Vaccine : EPAR - Scientific Discussion HR = Hrvatski 2011-07-08  
CVMP summary of positive opinion for MS-H vaccine HR = Hrvatski 2011-04-08