Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Draxxin   
Auth. number : EU/2/03/041
Active substance : Tulathromycin
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: QJ01FA94 - Tulathromycin
(See WHO ATCvet Index)
Indication: Cattle
Treatment and prevention of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis sensitive to tulathromycin. The presence of the disease in the herd should be established before preventative treatment.
Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to tulathromycin.
Pigs
Treatment and prevention of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae and Haemophilus parasuis sensitive to tulathromycin. The presence of the disease in the herd should be established before preventative treatment. DRAXXIN should only be used if pigs are expected to develop the disease within 2–3 days.
Marketing Authorisation Holder: Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique
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
13/11/2003 Centralised - Authorisation EMEA/V/C/77 (2003)4291 of 11/11/2003
12/01/2004 Centralised - Variation EMEA/V/C/77/IB/2
Updated with Decision(2004)3390 of 31/08/2004
12/01/2004 Centralised - Variation (no change in Commission Decision) EMEA/V/C/77/IB/1
26/04/2004 Centralised - Notification EMEA/V/C/77/3
Updated with Decision(2004)3390 of 31/08/2004
02/09/2004 Centralised - Variation EMEA/V/C/77 (2004)3390 of 31/08/2004
28/06/2005 Centralised - Variation EMEA/V/C/77/II/4 (2005)1978 of 24/06/2005
07/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/V/C/77/IA/5
22/02/2007 Centralised - Variation EMEA/V/C/77/II/6, 7 (2007)609 of 20/02/2007
05/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/V/C/77/IA/10, 11, 12, 13
23/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/V/C/77/IB/9
16/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/V/C/77/IB/14
18/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/V/C/77/IA/16
22/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/V/C/77/IB/15
10/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/77/IB/18
24/06/2008 Centralised - Variation EMEA/V/C/77/II/17 (2008)3203 of 20/06/2008
23/09/2008 Centralised - Renewal EMEA/V/C/77/R/19 (2008)5392 of 19/09/2008
17/03/2010 Centralised - Variation EMEA/V/C/77/II/20 (2010)1820 of 15/03/2010
07/10/2010 Corrigendum (2010)7030 corr of 05/10/2010
24/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/77/T/25 (2013)3106 of 22/05/2013
05/09/2013 Centralised - Variation EMEA/V/C/77/IAin/27
Updated with Decision(2014)4951 of 08/07/2014
10/07/2014 Centralised - Variation EMEA/V/C/77/X/26 (2014)4951 of 08/07/2014
20/11/2014 Centralised - Variation EMEA/V/C/77/IG/445/32
Updated with Decision(2015)2535 of 13/04/2015
14/01/2015 Centralised - Variation EMEA/V/C/77/IAIN/33
Updated with Decision(2015)2535 of 13/04/2015