Pharmaceuticals - Community Register


Community register of veterinary medicinal products


Product information

Invented name: STARTVAC   
Auth. number : EU/2/08/092
Active substance : inactivated vaccine for cattle
ATC: Anatomical main group: QI - Immunologicals
Therapeutic subgroup: QI02 - Immunologicals for bovidae
Pharmacological subgroup: QI02A - Cattle
Chemical subgroup: QI02AB - Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
Chemical substance: QI02AB - Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
(See WHO ATCvet Index)
Indication: Herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the clinical signs of clinical mastitis caused by Staphylococcus aureus, coliforms and coagulase-negative staphylococci.

The full immunisation scheme induces immunity from approximately day 13 after the first injection until approximately day 78 after the third injection
Marketing Authorisation Holder: Laboratorios Hipra, S.A.
Avda. La Selva, 135, 17170 Amer (Girona), España
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
13/02/2009 Centralised - Authorisation EMEA/V/C/130 (2009)1056 of 11/02/2009
12/02/2014 Centralised - Renewal EMEA/V/C/130/R/1 (2014)972 of 10/02/2014
24/07/2015 Centralised - Variation EMEA/V/C/130/IG/565
Updated with Decision(2016)4959 of 25/07/2016
10/09/2015 Centralised - Variation EMEA/V/C/130/II/3/G
Updated with Decision(2016)4959 of 25/07/2016
27/07/2016 Centralised - Yearly update (2016)4959 of 25/07/2016
15/02/2018 Centralised - Variation EMEA/V/C/130/II/5
02/03/2018 Centralised - Variation EMEA/V/C/130/IB/6