Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Zactran   
Auth. number : EU/2/08/082
INN : Gamithromycin
ATC: Anatomical main group: QJ - Antiinfectives for systemic use
Therapeutic subgroup: QJ01 - Antibacterials for systemic use
Pharmacological subgroup: QJ01F - Macrolides, lincosamides and streptogramins
Chemical subgroup: QJ01FA - Macrolides
Chemical substance: QJ01FA95 - Gamithromycin
(See WHO ATCvet Index)
Indication: Therapeutic and preventive treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
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
28/07/2008 Centralised - Authorisation EMEA/V/C/129 (2008)4053 of 24/07/2008
15/08/2008 Centralised - Variation EMEA/V/C/129/IA/1
03/03/2009 Centralised - Variation EMEA/V/C/129/IB/2
23/04/2009 Centralised - Variation EMEA/V/C/129/II/4
29/05/2009 Centralised - Variation EMEA/V/C/129/IA/6
29/05/2009 Centralised - Variation EMEA/V/C/129/IA/5
29/05/2009 Centralised - Variation EMEA/V/C/129/IA/7
23/07/2009 Centralised - Variation EMEA/V/C/129/II/3 (2009)5903 of 20/07/2009
24/08/2009 Centralised - Variation EMEA/V/C/129/IA/9
25/08/2009 Corrigendum
24/09/2009 Centralised - Variation EMEA/V/C/129/II/8
09/02/2010 Centralised - Variation EMEA/V/C/129/IB/12
10/02/2010 Centralised - Variation EMEA/V/C/129/IB/10
10/02/2010 Centralised - Variation EMEA/V/C/129/IB/13
10/02/2010 Centralised - Variation EMEA/V/C/129/IB/11
19/04/2010 Centralised - Variation EMEA/V/C/129/IB/14
Updated with Decision(2010)7628 of 28/10/2010
04/11/2010 Centralised - Variation (2010)7628 of 28/10/2010
06/12/2010 Centralised - Variation EMEA/V/C/129/IB/15/G
14/04/2011 Centralised - Variation EMEA/V/C/129/II/16 (2011)2695 of 12/04/2011
17/07/2013 Centralised - Renewal EMEA/V/C/129/R/21 (2013)4621 of 15/07/2013