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Community Register of medicinal products
Community register of veterinary medicinal products |
AUTHORISED |
Product information |
| Invented name: | Draxxin
|
| Auth. number : | EU/2/03/041 |
| INN : | Tulathromycin |
| ATC: | QJ - Antiinfectives for systemic use QJ01 - Antibacterials for systemic use QJ01F - Macrolides, lincosamides and streptogramins QJ01FA - Macrolides QJ01FA94 - Tulathromycin (See WHO ATCvet Index) |
| Indication: | Treatment and prevention of bovine and swine respiratory disease (BRD) |
| Marketing Authorisation Holder: | Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
EPAR and active package presentations
Package presentations
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register. |
European Commission procedures
| 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 | EMEA/V/C/77/IB/1 | ||||
| 26/04/2004 | Centralised - Variation | 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 | 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 | EMEA/V/C/77/IA/10, 13 | ||||
| 23/03/2007 | Centralised - Variation | EMEA/V/C/77/IB/9 | ||||
| 16/05/2007 | Centralised - Variation | EMEA/V/C/77/IB/14 | ||||
| 18/10/2007 | Centralised - Variation | EMEA/V/C/77/IA/16 | ||||
| 22/11/2007 | Centralised - Variation | EMEA/V/C/77/IB/15 | ||||
| 10/01/2008 | Centralised - Variation | 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 |