Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Procox   
Auth. number : EU/2/11/123
Active substance : emodepside & toltrazuril
ATC: Anatomical main group: QP - Antiparasitic products, insecticides and repellents
Therapeutic subgroup: QP52 - Anthelmintics
Pharmacological subgroup: QP52A - Anthelmintics
Chemical subgroup: QP52AX - Other anthelmintic agents
Chemical substance: QP52AX60 - Emodepside and toltrazuril
(See WHO ATCvet Index)
Indication: For dogs, when mixed parasitic infections caused by roundworms and coccidia of the following species are suspected or demonstrated:
Roundworms (Nematodes):
- Toxocara canis (mature adult, immature adult, L4)
- Uncinaria stenocephala (mature adult) - Ancylostoma caninum (mature adult) - Trichuris vulpis (mature adult) Coccidia: - Isospora ohioensis complex
- Isospora canis Procox is effective against the replication of Isospora and also against the shedding of oocysts.
Although treatment will reduce the spread of infection, it will not be effective against the clinical
signs of infection in already infected animals.
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
28/04/2011 Centralised - Authorisation EMEA/V/C/2006 (2011)2949 of 20/04/2011
01/08/2011 Centralised - Variation EMEA/V/C/2006/IB/1
Updated with Decision(2012)642 of 31/01/2012
02/02/2012 Centralised - Variation (2012)642 of 31/01/2012
15/06/2012 Centralised - Variation EMEA/V/C/2006/IB/5/G
Updated with Decision(2012)7913 of 29/10/2012
08/11/2012 Centralised - Variation EMEA/V/C/2006/IB/8
Updated with Decision(2012)9540 of 10/12/2012
14/11/2012 Centralised - Variation (2012)7913 of 29/10/2012
12/12/2012 Centralised - Variation EMEA/V/C/2006/II/6 (2012)9540 of 10/12/2012
05/09/2013 Centralised - Variation EMEA/V/C/2006/IAin/9
Updated with Decision(2014)6187 of 26/08/2014
28/02/2014 Centralised - Variation EMEA/V/C/2006/IAin/10
Updated with Decision(2014)6187 of 26/08/2014
28/08/2014 Centralised - Yearly update (2014)6187 of 26/08/2014
11/03/2015 Centralised - Variation EMEA/V/C/2006/IAin/11
Updated with Decision(2016)238 of 14/01/2016
18/01/2016 Centralised - Renewal EMEA/V/C/2006/R/12 (2016)238 of 14/01/2016
11/04/2016 Centralised - Variation EMEA/V/C/2006/IA/15
Updated with Decision(2017)2542 of 11/04/2017
05/09/2016 Centralised - Variation EMEA/V/C/2006/IAIN/0017
Updated with Decision(2017)2542 of 11/04/2017
22/02/2017 Centralised - Variation EMEA/V/C/002006/IAIN/0018
Updated with Decision(2017)2542 of 11/04/2017
19/04/2017 Centralised - Yearly update (2017)2542 of 11/04/2017
18/05/2017 Centralised - Variation EMEA/V/C/002006/IAIN/0019
27/05/2017 Centralised - Variation EMEA/V/C/002006/IAIN/0016
Updated with Decision(2017)2542 of 11/04/2017