Pharmaceuticals - Community Register


Community register of veterinary medicinal products


Product information

Invented name: Vaxxitek HVT + IBD   
Auth. number : EU/2/02/032
Active substance : Live vHVT013-69 recombinant virus
ATC: Anatomical main group: QI - Immunologicals
Therapeutic subgroup: QI01 - Immunologicals for aves
Pharmacological subgroup: QI01A - Domestic fowl
Chemical subgroup: QI01AD - Live viral vaccines
Chemical substance: QI01AD15 - Avian infectious bursal disease virus (Gumboro disease) + avian herpes virus (Marek´s disease)
(See WHO ATCvet Index)
Indication: Live recombinant vaccine against Infectious Bursal Disease and Marek’s Disease
Marketing Authorisation Holder: Merial
29 avenue Tony Garnier, F-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
13/08/2002 Centralised - Authorisation EMEA/V/C/65 (2002)3126 of 09/08/2002
17/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/V/C/65/I/2
23/10/2003 Centralised - Variation EMEA/V/C/65/I/3, 4 (2003)3932 of 17/10/2003
26/03/2004 Centralised - Variation EMEA/V/C/65/X/1 (2004)1195 of 25/03/2004
03/01/2006 Centralised - Variation EMEA/V/C/65/IB/5
Updated with Decision(2006)3306 of 14/07/2006
18/07/2006 Centralised - Variation (2006)3306 of 14/07/2006
23/08/2006 Centralised - Variation EMEA/V/C/65/II/6 (2006)3834 of 21/08/2006
15/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/V/C/65/II/7
19/06/2007 Centralised - Renewal EMEA/V/C/65/R/8 (2007)3030 of 14/06/2007
15/10/2008 Centralised - Variation EMEA/V/C/65/II/9 (2008)6048 of 13/10/2008
23/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/65/II/10
29/04/2010 Centralised - Variation EMEA/V/C/65/II/11 (2010)2843 of 27/04/2010
10/07/2012 Centralised - Renewal EMEA/V/C/65/R/12 (2012)4845 of 06/07/2012
03/01/2014 Centralised - Variation (no change in Commission Decision) EMEA/V/C/65/IA/13
11/09/2014 Centralised - Variation EMEA/V/C/65/WS/546/14