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Pharmaceuticals - Community Register
Community register of veterinary medicinal products |
AUTHORISED |
Product information |
Invented name: | Econor
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Auth. number : | EU/2/98/010 |
Active substance : | 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% premix for medicated feed for 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. Econor 10% premix for medicated feed for pigs and rabbits 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: | Elanco Europe Ltd.
Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, 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 procedures |
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 - Authorisation | EMEA/V/C/42/II/4 | (2000)2572 of 15/09/2000 | |||
20/09/2000 | Centralised - Variation | EMEA/V/C/42/II/5 | (2000)2571 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/IA/24 | ||||
30/07/2008 | Centralised - Variation (no change in Commission Decision) | EMEA/V/C/42/IB/25 | ||||
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/28 | ||||
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/29 | ||||
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 | |||
01/03/2016 | Centralised - Transfer Marketing Authorisation Holder | EMEA/V/C/42/T/48 | (2016)1352 of 26/02/2016 | |||
07/06/2016 | Centralised - Variation | EMEA/V/C/42/IG0681 | ||||
Updated with Decision(2017)4057 of 07/06/2017 | ||||||
09/06/2017 | Centralised - Yearly update | (2017)4057 of 07/06/2017 | ||||
12/07/2017 | Centralised - Variation | EMEA/V/C/42/IB/51 | ||||