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Community register of veterinary medicinal products


Product information

Invented name: Bovalto Ibraxion   
Auth. number : EU/2/99/017
Active substance : Not available
ATC: Anatomical main group: QI - Immunologicals
Therapeutic subgroup: QI02 - Immunologicals for bovidae
Pharmacological subgroup: QI02A - Cattle
Chemical subgroup: QI02AA - Inactivated viral vaccines
Chemical substance: QI02AA03 - ivermectin
(See WHO ATCvet Index)
Indication: Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.
Marketing Authorisation Holder: Merial
29 avenue Tony Garnier, 69007 Lyon, France
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
10/03/2000 Centralised - Authorisation EMEA/V/C/51 (2000)575 of 09/03/2000
03/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/V/C/51/II/2
18/11/2002 Centralised - Notification (2002)4528 of 14/11/2002
18/02/2003 Centralised - Variation EMEA/V/C/51/II/3 (2003)599 of 14/02/2003
28/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/V/C/51/I/5
24/09/2003 Centralised - Variation EMEA/V/C/51/I/6, 7 (2003)3420 of 22/09/2003
29/04/2005 Centralised - Renewal EMEA/V/C/51/R/8 (2005)1393 of 27/04/2005
12/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/51/IB/9
14/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/51/II/10
23/03/2010 Centralised - Renewal EMEA/V/C/51/R/11 (2010)1997 of 23/03/2010
10/08/2016 Centralised - Variation EMEA/V/C/51/IAIN/16
Updated with Decision(2017)6487 of 21/09/2017
25/09/2017 Centralised - Yearly update (2017)6487 of 21/09/2017