Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products
AUTHORISED  

Product information
Invented name: Econor   
Auth. number : EU/2/98/010
INN : Valnemulin hydrochloride
ATC: Anatomical main group: QJ - Antiinfectives for systemic use
Therapeutic subgroup: QJ01 - Antibacterials for systemic use
Pharmacological subgroup: QJ01X - Other antibacterials
Chemical subgroup: QJ01XQ - Pleuromutilins
Chemical substance: QJ01XQ02 - Valnemulin
(See WHO ATCvet Index)
Indication: Econor 50%
The treatment and prevention of swine dysentery.
The treatment of clinical signs of porcine proliferative enteropathy (ileitis).
The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been diagnosed in the herd.
Treatment and prevention of swine enzootic pneumonia. At the recommended dosage of 10–12 mg/kg bodyweight lung lesions and weight loss are reduced, but infection with Mycoplasma hyopneumoniae is not eliminated.
Econor 10%
Pigs:
The treatment and prevention of swine dysentery.
The treatment of clinical signs of porcine proliferative enteropathy (ileitis).
The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been diagnosed in the herd.
Treatment and prevention of swine enzootic pneumonia. At the recommended dosage of 10–12 mg/kg bodyweight lung lesions and weight loss are reduced, but infection with Mycoplasma hyopneumoniae is not eliminated.
Rabbits:
Reduction of mortality during an outbreak of epizootic rabbit enteropathy (ERE).
Treatment should be started early in the outbreak, when the first rabbit has been diagnosed with the disease clinically.
Econor 10% oral powder for pigs: Treatment of swine dysentery caused by Brachyspira hyodysenteriae.
Treatment of clinical signs of porcine proliferative enteropathy (ileitis) caused by Lawsonia intracellularis.
Treatment of swine enzootic pneumonia caused by Mycoplasma hyopneumoniae.
Marketing Authorisation Holder: Novartis Tiergesundheit GmbH
Zielstattstrasse 40, D-81379 München, Deutschland

  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
16/03/1999 Centralised - Authorisation EMEA/V/C/42 (1999)578 of 12/03/1999
09/11/1999 Centralised - Variation (no change in Commission Decision) EMEA/V/C/42/3/I/3
25/11/1999 Centralised - Variation EMEA/V/C/42//I/1 (1999)3795 of 16/11/1999
02/02/2000 Centralised - Variation EMEA/V/C/42/II/2 (2000)128 of 31/01/2000
20/09/2000 Centralised - Variation EMEA/V/C/42/II/5 (2000)2571 of 15/09/2000
20/09/2000 Centralised - Authorisation EMEA/V/C/42/II/4 (2000)2572 of 15/09/2000
22/09/2000 Centralised - Authorisation EMEA/V/C/42/II/6 (2000)2582 of 19/09/2000
29/11/2000 Centralised - Variation (no change in Commission Decision) EMEA/V/C/42/I/8
22/12/2000 Centralised - Suspension of martketing authorisation EMEA/V/C/42/Z (2000)3951 of 20/12/2000
07/02/2001 Centralised - Variation EMEA/V/C/42/I/7 (2001)220 of 06/02/2001
31/01/2002 Centralised - Suspension of martketing authorisation EMEA/V/C/42/ (2002)410 of 29/01/2002
30/04/2002 Centralised - Lift of suspension EMEA/V/C/42 (2002)1792 of 26/04/2002
23/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/V/C/42/I/16, 17
13/11/2003 Centralised - Variation (no change in Commission Decision) EMEA/V/C/42/II/14
15/12/2003 Centralised - Variation (no change in Commission Decision) EMEA/V/C/42/I/15
29/01/2004 Centralised - Variation EMEA/V/C/42/II/12, 13 (2004)224 of 27/01/2004
02/04/2004 Centralised - Renewal EMEA/V/C/42/R/18 (2004)1323 of 31/03/2004
06/10/2004 Centralised - Variation EMEA/V/C/42/IA/19
Updated with Decision(2005)1635 of 26/05/2005
03/05/2005 Centralised - Variation EMEA/V/C/42/IB/20
Updated with Decision(2005)1635 of 26/05/2005
30/05/2005 Centralised - Annual reassessment EMEA/V/C/42/S/21 (2005)1635 of 26/05/2005
01/07/2005 Centralised - Variation EMEA/V/C/42/IA/22
Updated with Decision(2006)387 of 03/02/2006
07/02/2006 Centralised - Variation (2006)387 of 03/02/2006
06/09/2007 Centralised - Variation EMEA/V/C/42/II/23 (2007)4201 of 04/09/2007
30/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/42/IB/25
30/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/42/IA/24
15/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/42/IA/27
15/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/42/IA/29
15/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/42/IA/30
15/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/42/IA/26
15/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/42/IA/28
10/03/2009 Centralised - Renewal EMEA/V/C/42/R/31 (2009)1715 of 06/03/2009
12/05/2009 Centralised - Variation EMEA/V/C/42/II/32 (2009)3861 of 08/05/2009
29/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/42/IB/35/G
15/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/42/IB/36/G
11/01/2011 Centralised - Variation EMEA/V/C/42/X/33 (2011)77 of 06/01/2011
01/04/2011 Centralised - Variation (no change in Commission Decision) EMEA/V/C/42/IB/37/G
08/05/2013 Centralised - Variation EMEA/V/C/42/IB/42
Updated with Decision(2013)5295 of 05/08/2013
09/08/2013 Centralised - Variation EMEA/V/C/42/X/39 (2013)5295 of 05/08/2013
13/03/2014 Centralised - Variation EMEA/V/C/42/IB/45
Updated with Decision(2014)4363 of 23/06/2014
25/06/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/42/T/47 (2014)4363 of 23/06/2014