Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Aivlosin   
Auth. number : EU/2/04/044
INN : Tylvalosin
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: QJ01FA92 - Acetyl isovaleryl tylosin
(See WHO ATCvet Index)
Indication: Pigs:
• Treatment and prevention of swine enzootic pneumonia caused by susceptible strains of Mycoplasma hyopneumoniae in pigs. At the recommended dose, lung lesions and weight loss are reduced but infection with Mycoplasma hyopneumoniae is not eliminated.
• Treatment of porcine proliferative enteropathy (ileitis) caused by Lawsonia intracellularis in herds where there is a diagnosis based on clinical history, post-mortem findings and clinical pathology results.
• Treatment of clinical outbreaks of swine dysentery, caused by Brachyspira hyodysenteriae in herds where the disease has been diagnosed and prevention of further clinical cases.

Pheasants
Treatment of respiratory disease associated with Mycoplasma gallisepticum in pheasants.

Chickens
Treatment and prevention of respiratory disease associated with Mycoplasma gallisepticum in chickens.
As an aid in the prevention strategy to reduce the clinical signs and mortality from respiratory disease in flocks, where infection in ovum with Mycoplasma gallisepticum is likely because the disease is known to exist in the parent generation. The prevention strategy should include efforts to eliminate the infection from the parent generation.
 
Turkeys
Treatment of respiratory disease associated with tylvalosin sensitive strains of Ornithobacterium rhinotracheale in turkeys.
Marketing Authorisation Holder: ECO Animal Health Ltd
78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom

  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
13/09/2004 Centralised - Authorisation EMEA/V/C/83 (2004)3472 of 09/09/2004
13/10/2004 Centralised - Notification EMEA/V/C/83/N/1
Updated with Decision(2005)1248 of 15/04/2005
24/02/2005 Centralised - Notification EMEA/V/C/83/N/9
Updated with Decision(2005)1248 of 15/04/2005
19/04/2005 Centralised - Variation EMEA/V/C/83/II/2 (2005)1248 of 15/04/2005
19/05/2005 Centralised - Variation (no change in Commission Decision) EMEA/V/C/83/II/6
20/06/2005 Centralised - Variation EMEA/V/C/83/II/3 (2005)1878 of 16/06/2005
12/07/2005 Centralised - Notification EMEA/V/C/83/N/11
Updated with Decision(2006)335 of 02/02/2006
12/07/2005 Centralised - Variation EMEA/V/C/83/IB/12
Updated with Decision(2006)335 of 02/02/2006
12/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/V/C/83/II/10
10/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/V/C/83/IB/13
06/02/2006 Centralised - Variation EMEA/V/C/83/X/7, 8 (2006)335 of 02/02/2006
17/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/V/C/83/IA/14
24/05/2006 Centralised - Variation EMEA/V/C/83/II/4, 5 (2006)2151 of 22/05/2006
17/07/2006 Centralised - Variation EMEA/V/C/83/IB/17
Updated with Decision(2007)670 of 23/02/2007
07/08/2006 Centralised - Variation EMEA/V/C/83/IB/15
07/08/2006 Centralised - Variation EMEA/V/C/83/IB/16
07/08/2006 Centralised - Variation EMEA/V/C/83/IB/18
Updated with Decision(2007)670 of 23/02/2007
08/09/2006 Centralised - Variation EMEA/V/C/83/IB/19
Updated with Decision(2007)670 of 23/02/2007
08/09/2006 Centralised - Variation EMEA/V/C/83/IB/20
Updated with Decision(2007)670 of 23/02/2007
14/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/V/C/83/IA/23
10/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/V/C/83/IA/24
17/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/V/C/83/IA/25
27/02/2007 Centralised - Variation (2007)670 of 23/02/2007
25/05/2007 Centralised - Variation EMEA/V/C/83/IA/28
Updated with Decision(2007)6767 of 19/12/2007
16/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/V/C/83/II/27
21/12/2007 Centralised - Variation (2007)6767 of 19/12/2007
07/02/2008 Centralised - Variation EMEA/V/C/83/II/29 (2008)522 of 05/02/2008
25/02/2008 Centralised - Variation EMEA/V/C/83/IB/30
Updated with Decision(2008)2597 of 04/06/2008
06/06/2008 Centralised - Variation EMEA/V/C/83/X/26 (2008)2597 of 04/06/2008
16/07/2008 Centralised - Notification EMEA/V/C/83/N/33
Updated with Decision(2008)6217 of 20/10/2008
22/10/2008 Centralised - Variation EMEA/V/C/83/II/31 (2008)6217 of 20/10/2008
20/03/2009 Centralised - Variation EMEA/V/C/83/II/34 (2009)2099 of 18/03/2009
13/05/2009 Centralised - Variation EMEA/V/C/83/X/32 (2009)3902 of 11/05/2009
31/08/2009 Centralised - Renewal EMEA/V/C/83/R/38 (2009)6715 of 27/08/2009
07/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/83/IB/39
25/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/83/IB/41
25/11/2009 Centralised - Variation EMEA/V/C/83/IB/42
Updated with Decision(2010)1814 of 15/03/2010
26/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/83/IB/40
16/12/2009 Centralised - Variation EMEA/V/C/83/X/36, 37 (2009)10393 of 14/12/2009
17/03/2010 Centralised - Variation (2010)1814 of 15/03/2010
12/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/83/IB/43
17/11/2010 Centralised - Variation EMEA/V/C/83/IB/44/G
Updated with Decision(2011)3609 of 18/05/2011
14/03/2011 Centralised - Variation EMEA/V/C/83/IB/45/G
Updated with Decision(2011)3609 of 18/05/2011
23/05/2011 Centralised - Variation (2011)3609 of 18/05/2011
31/08/2011 Centralised - Variation EMEA/V/C/83/IB/46
Updated with Decision(2012)2171 of 26/03/2012
05/03/2012 Centralised - Variation EMEA/V/C/83/IA/49
Updated with Decision(2012)2171 of 26/03/2012
28/03/2012 Centralised - Variation (2012)2171 of 26/03/2012
20/11/2012 Centralised - Variation EMEA/V/C/83/IB/53
Updated with Decision(2013)8895 of 04/12/2013
20/12/2012 Centralised - Variation EMEA/V/C/83/IB/54
Updated with Decision(2013)8895 of 04/12/2013
06/12/2013 Centralised - Variation EMEA/V/C/83/X/51 (2013)8895 of 04/12/2013
16/01/2014 Centralised - Variation EMEA/V/C/83/IAin/58
Updated with Decision(2014)6476 of 09/09/2014
11/09/2014 Centralised - Renewal EMEA/V/C/83/R/59 (2014)6476 of 09/09/2014
21/11/2014 Centralised - Variation EMEA/V/C/83/IAIN/61