Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Metacam   
Auth. number : EU/2/97/004
INN : Meloxicam
ATC: Anatomical main group: QM - Musculo-skeletal system
Therapeutic subgroup: QM01 - Antiinflammatory and antirheumatic products
Pharmacological subgroup: QM01A - Antiinflammatory and antirheumatic products, non-steroids
Chemical subgroup: QM01AC - Oxicams
Chemical substance: QM01AC06 - Meloxicam
(See WHO ATCvet Index)
Indication: Dogs:
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

Dogs and cats:
Dogs:
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Cats:
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.
Alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders in cats.

Cattle, pigs and horses:
Cattle:
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
For the relief of post-operative pain following dehorning in calves.
Pigs:
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.
For the relief of post-operative pain associated with minor soft tissue surgery such as castration.
Horses:
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.
For the relief of pain associated with equine colic.
Marketing Authorisation Holder: Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein, 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
08/01/1998 Centralised - Authorisation EMEA/V/C/33 (97)4312 of 07/01/1998
27/03/2000 Centralised - Authorisation EMEA/V/C/33/X/3, 4, 5 (2000)770 of 24/03/2000
27/03/2000 Centralised - Authorisation EMEA/V/C/33/X/2 (2000)767 of 24/03/2000
20/07/2000 Centralised - Variation EMEA/V/C/33/I/2 (2000)2027 of 13/07/2000
03/08/2000 Centralised - Variation EMEA/V/C/33/3/I/1 (2000)2329 of 27/07/2000
18/09/2000 Centralised - Variation EMEA/V/C/33/X (2000)2574 of 15/09/2000
10/10/2000 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/I/5, 6, 7
10/10/2000 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/I/6, 7
08/12/2000 Centralised - Variation EMEA/V/C/33/I/3, 4 (2000)3480 of 07/12/2000
25/04/2001 Centralised - Variation EMEA/V/C/33/X/7, 8 (2001)848 of 23/04/2001
20/11/2001 Centralised - Notification EMEA/V/C/33/N/11 (2001)3556 of 19/11/2001
08/02/2002 Centralised - Variation EMEA/V/C/33/II/15 (2002)498 of 06/02/2002
15/03/2002 Centralised - Notification EMEA/V/C/33/N/16 (2002)1130 of 13/03/2002
11/07/2002 Centralised - Notification EMEA/V/C/33/N/17 (2002)2682 of 09/07/2002
15/07/2002 Centralised - Notification EMEA/V/C/33/N/18 (2002)2708 of 10/07/2002
13/08/2002 Centralised - Variation EMEA/V/C/33/X/13 (2002)3128 of 09/08/2002
30/10/2002 Centralised - Notification EMEA/V/C/33/N/19 (2002)4335 of 28/10/2002
22/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/I/23
31/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/I/24
19/03/2003 Centralised - Renewal EMEA/V/C/33/R/20 (2003)852 of 17/03/2003
14/05/2003 Centralised - Variation EMEA/V/C/33/X/16 (2003)1617 of 12/05/2003
14/05/2003 Centralised - Variation EMEA/V/C/33/X/18 (2003)1614 of 12/05/2003
06/06/2003 Centralised - Variation EMEA/V/C/33/I/27 (2003)1847 of 04/06/2003
07/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/I/30
07/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/I/29
24/07/2003 Centralised - Variation EMEA/V/C/33/II/25 (2003)2741 of 22/07/2003
05/08/2003 Centralised - Variation EMEA/V/C/33/I/28 (2003)2900 of 01/08/2003
05/08/2003 Centralised - Variation EMEA/V/C/33/I/31 (2003)2899 of 01/08/2003
12/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/I/32
10/10/2003 Centralised - Variation EMEA/V/C/33/II/26 (2003)3731 of 08/10/2003
10/10/2003 Centralised - Variation EMEA/V/C/33/X/22 (2003)3739 of 08/10/2003
30/01/2004 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/IA/34
23/03/2004 Centralised - Variation EMEA/V/C/33/X/33 (2004)1050 of 19/03/2004
02/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/IA/35
30/04/2004 Centralised - Notification EMEA/V/C/33/N/36, 37, 38, 39
Updated with Decision(2005)1394 of 27/04/2005
28/09/2004 Centralised - Variation EMEA/V/C/33/IA/43
Updated with Decision(2005)1394 of 27/04/2005
28/09/2004 Centralised - Variation EMEA/V/C/33/IA/44
Updated with Decision(2005)1394 of 27/04/2005
02/02/2005 Centralised - Variation EMEA/V/C/33/X/40 (2005)277 of 31/01/2005
21/02/2005 Centralised - Notification EMEA/V/C/33/N/49
Updated with Decision(2005)1976 of 24/06/2005
15/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/IB/46
16/03/2005 Centralised - Variation EMEA/V/C/33/IB/47
Updated with Decision(2005)1976 of 24/06/2005
29/03/2005 Centralised - Notification EMEA/V/C/33/N/41
Updated with Decision(2005)1394 of 27/04/2005
29/04/2005 Centralised - Variation (2005)1394 of 27/04/2005
28/06/2005 Centralised - Variation EMEA/V/C/33/II/48 (2005)1976 of 24/06/2005
13/07/2005 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/IB/52
13/07/2005 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/IB/51
25/07/2005 Centralised - Variation EMEA/V/C/33/IB/54
Updated with Decision(2006)220 of 25/01/2006
25/07/2005 Centralised - Variation EMEA/V/C/33/IB/53
Updated with Decision(2006)220 of 25/01/2006
03/08/2005 Centralised - Variation EMEA/V/C/33/X/42 (2005)3044 of 01/08/2005
27/01/2006 Centralised - Variation EMEA/V/C/33/II/55 (2006)220 of 25/01/2006
07/02/2006 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/IA/56
28/03/2006 Centralised - Variation EMEA/V/C/33/X/50 (2006)1105 of 23/03/2006
26/10/2006 Centralised - Variation EMEA/V/C/33/IB/59
Updated with Decision(2007)608 of 20/02/2007
27/10/2006 Centralised - Variation EMEA/V/C/33/IB/60
Updated with Decision(2007)608 of 20/02/2007
22/02/2007 Centralised - Variation EMEA/V/C/33/II/61 (2007)608 of 20/02/2007
19/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/IA/64
24/04/2007 Centralised - Variation EMEA/V/C/33/II/58 (2007)1856 of 20/04/2007
16/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/IA/66
18/05/2007 Centralised - Variation EMEA/V/C/33/II/65 (2007)2191 of 15/05/2007
26/06/2007 Centralised - Variation EMEA/V/C/33/IB/67
Updated with Decision(2007)6264 of 06/12/2007
26/06/2007 Centralised - Variation EMEA/V/C/33/IB/68
Updated with Decision(2007)6264 of 06/12/2007
10/12/2007 Centralised - Renewal EMEA/V/C/33/R/69 (2007)6264 of 06/12/2007
22/02/2008 Centralised - Variation EMEA/V/C/33/IB/70
Updated with Decision(2008)2187 of 21/05/2008
23/05/2008 Centralised - Variation EMEA/V/C/33/II/71 (2008)2187 of 21/05/2008
11/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/IB/73
12/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/IB/72
22/07/2009 Centralised - Variation EMEA/V/C/33/IB/76
Updated with Decision(2009)9332 of 20/11/2009
21/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/II/77
30/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/33/IB/80
24/11/2009 Centralised - Variation EMEA/V/C/33/II/78 (2009)9332 of 20/11/2009
13/01/2010 Corrigendum EMEA/V/C/33/II/78 (2010)66 of 08/01/2010
14/01/2010 Centralised - Variation EMEA/V/C/33/II/75 (2010)116 of 12/01/2010
19/05/2010 Centralised - Variation EMEA/V/C/33/IA/82
Updated with Decision(2010)9622 of 20/12/2010
04/06/2010 Centralised - Variation EMEA/V/C/33/II/81 (2010)3632 of 02/06/2010
07/07/2010 Centralised - Variation EMEA/V/C/33/X/79 (2010)4780 of 05/07/2010
07/07/2010 Centralised - Variation EMEA/V/C/33/X/74 (2010)4702 of 02/07/2010
17/11/2010 Centralised - Variation EMEA/V/C/33/IB/86
Updated with Decision(2011)4637 of 23/06/2011
24/11/2010 Centralised - Variation EMEA/V/C/33/IA/87
Updated with Decision(2011)4637 of 23/06/2011
23/12/2010 Centralised - Variation EMEA/V/C/33/II/83/G (2010)9622 of 20/12/2010
10/02/2011 Centralised - Variation EMEA/V/C/33/IB/88/G
Updated with Decision(2011)4637 of 23/06/2011
11/04/2011 Centralised - Variation EMEA/V/C/33/IB/89
Updated with Decision(2011)4637 of 23/06/2011
28/06/2011 Centralised - Variation EMEA/V/C/33/II/84 (2011)4637 of 23/06/2011
08/07/2011 Centralised - Variation EMEA/V/C/33/IB/90
Updated with Decision(2012)641 of 31/01/2012
25/08/2011 Centralised - Variation EMEA/V/C/33/IB/91
Updated with Decision(2012)641 of 31/01/2012
12/10/2011 Centralised - Variation EMEA/V/C/33/IB/92
Updated with Decision(2012)641 of 31/01/2012
02/02/2012 Centralised - Variation (2012)641 of 31/01/2012
12/12/2012 Centralised - Variation EMEA/V/C/33/WS/264 (2012)9546 of 10/12/2012
14/06/2013 Centralised - Variation EMEA/V/C/33/IB/103
Updated with Decision(2014)3953 of 06/06/2014
11/04/2014 Centralised - Variation EMEA/V/C/33/IB/109
Updated with Decision(2014)3953 of 06/06/2014
11/06/2014 Centralised - Yearly update (2014)3953 of 06/06/2014