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Community register of veterinary medicinal products


Product information

Invented name: MS-H vaccine   

   This product is authorised under a different brand name in the EU in the following languages:
   - Ваксина MS-H (BG)
   - Vakcína MS-H (CS)
   - MS-H Vaccine (DA)
   - MS-H Impfstoff (DE)
   - MS-H Vaccine (EL)
   - MS-H Vaccine (ES)
   - MS-H vaktsiin (ET)
   - MS-H-rokote (FI)
   - Vaccin MS-H (FR)
   - MS-H vakcina (HU)
   - Vaccino MS-H (IT)
   - MS-H Vaccine (LT)
   - MS-H Vaccine (LV)
   - Vaċċine MS-H (MT)
   - MS-H Vaccin (NL)
   - MS-H Vaccine (PL)
   - Vacina MS-H (PT)
   - Vaccin MS-H (RO)
   - Vakcína MS-H (SK)
   - Cepivo MS-H (SL)
   - MS-H Vaccin (SV)
Auth. number : EU/2/11/126
Active substance : Mycoplasma synoviae Strain MS-H live attenuated thermosensitive
ATC: Anatomical main group: QI - Immunologicals
Therapeutic subgroup: QI01 - Immunologicals for aves
Pharmacological subgroup: QI01A - Domestic fowl
Chemical subgroup: QI01AE - Live bacterial vaccines
Chemical substance: QI01AE03 - mycoplasma
(See WHO ATCvet Index)
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.
Onset of immunity: 4 weeks after vaccination.
The duration of immunity to reduce air sac lesions has been demonstrated to be 40 weeks post vaccination.
The duration of immunity to reduce the number of eggs with abnormal shell formation has not yet been demonstrated
Marketing Authorisation Holder: Pharmsure International Ltd
Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
16/06/2011 Centralised - Authorisation EMEA/V/C/161 (2011)4296 of 14/06/2011
09/12/2011 Corrigendum (2011)4296 of 14/06/2011
26/03/2014 Centralised - Variation EMEA/V/C/161/IA/6
Updated with Decision(2015)3161 of 05/05/2015
07/05/2015 Centralised - Yearly update (2015)3161 of 05/05/2015
26/10/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/161/T/7 (2015)7390 of 22/10/2015
26/10/2015 Rectificative Decision (2015)7391 of 22/10/2015
19/05/2016 Centralised - Renewal EMEA/V/C/161/R/9 (2016)3091 of 17/05/2016