Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Procox   
Auth. number : EU/2/11/123
INN : 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)
    • 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
    28/02/2014 Centralised - Variation EMEA/V/C/2006/IAin/10