Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Advocate   
Auth. number : EU/2/03/039
Active substance : imidacloprid & moxidectin
ATC: Anatomical main group: QP - Antiparasitic products, insecticides and repellents
Therapeutic subgroup: QP54 - Endectocides
Pharmacological subgroup: QP54A - Macrocyclic lactones
Chemical subgroup: QP54AB - Milbemycins
Chemical substance: QP54AB52 - Moxidectin, combinations
(See WHO ATCvet Index)
Indication: For cats suffering from, or at risk from, mixed parasitic infections:
• For the treatment and prevention of flea infestation (Ctenocephalides felis),
• the treatment of ear mite infestation (Otodectes cynotis),
• the treatment of notoedric mange (Notoedres cati),
• the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis),
• the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara cati and Ancylostoma tubaeforme).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
For ferrets suffering from, or at risk from, mixed parasitic infections:
• For the treatment and prevention of flea infestation (Ctenocephalides felis),
• the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis).

For dogs suffering from, or at risk from, mixed parasitic infections:
• For the treatment and prevention of flea infestation (Ctenocephalides felis),
• the treatment of biting lice (Trichodectes canis),
• the treatment of ear mite infestation (Otodectes cynotis), sarcoptic mange (caused by Sarcoptes scabiei var. canis), demodicosis (caused by Demodex canis),
• the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis),
• the treatment of circulating microfilariae (Dirofilaria immitis),
• the prevention of cutaneous dirofilariosis (L3 larvae of Dirofilaria repens),
• the reduction of circulating microfilariae (Dirofilaria repens),
• the prevention of angiostrongylosis (L4 larvae and immature adults of Angiostrongylus vasorum),
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• the treatment of Angiostrongylus vasorum and Crenosoma vulpis,
• the prevention of spirocercosis (Spirocerca lupi),
• the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara canis, Ancylostoma caninum and Uncinaria stenocephala, adults of Toxascaris leonina and Trichuris vulpis).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Marketing Authorisation Holder: Bayer Animal Health GmbH
D-51368 Leverkusen, 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
04/04/2003 Centralised - Authorisation EMEA/V/C/76 (2003)1204 of 02/04/2003
06/06/2003 Centralised - Variation EMEA/V/C/76/N/1, 2 (2003)1845 of 04/06/2003
18/02/2004 Centralised - Variation EMEA/V/C/76/IB/3
Updated with Decision(2004)1485 of 13/04/2004
16/04/2004 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/76/T/4 (2004)1485 of 13/04/2004
07/01/2005 Centralised - Variation EMEA/V/C/76/II/5 (2005)13 of 05/01/2004
04/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/V/C/76/IA/6
19/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/V/C/76/IA/4
26/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/V/C/76/IA/7
08/12/2006 Centralised - Variation EMEA/V/C/76/IB/8
Updated with Decision(2007)3502 of 16/07/2007
18/07/2007 Centralised - Variation (2007)3502 of 16/07/2007
15/08/2007 Centralised - Variation EMEA/V/C/76/II/9 (2007)3951 of 13/08/2007
11/02/2008 Centralised - Renewal EMEA/V/C/76/R/10 (2008)561 of 07/02/2008
04/09/2008 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/76/T/11 (2008)4948 of 02/09/2008
12/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/76/IA/13
27/05/2009 Centralised - Variation EMEA/V/C/76/II/12 (2009)4182 of 25/05/2009
25/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/76/IB/15/G
30/08/2010 Centralised - Variation EMEA/V/C/76/II/14 (2010)5997 of 26/08/2010
13/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/76/IA/16/G
15/11/2010 Centralised - Variation EMEA/V/C/76/IB/17/G
Updated with Decision(2011)4299 of 14/06/2011
16/06/2011 Centralised - Variation (2011)4299 of 14/06/2011
16/01/2013 Centralised - Renewal EMEA/V/C/76/R/21 (2013)131 of 14/01/2013
22/10/2013 Centralised - 2-Monthly update EMEA/V/C/76/II/22 (2013)7043 of 18/10/2013
06/03/2014 Centralised - Variation EMEA/V/C/76/IA/25
Updated with Decision(2015)1566 of 05/03/2015
09/03/2015 Centralised - Yearly update (2015)1566 of 05/03/2015