Procox

RSS

emodepside / toltrazuril

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 21/03/2018

Authorisation details

Product details
Name
Procox
Agency product number
EMEA/V/C/002006
Active substance
emodepside / toltrazuril
International non-proprietary name (INN) or common name
emodepside / toltrazuril
Species
Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QP52AX60
Publication details
Marketing-authorisation holder
Bayer Animal Health GmbH
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
20/04/2011
Contact address
D-51368 Leverkusen
Germany

Product information

13/03/2018 Procox - EMEA/V/C/002006 - IAIN/0025

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antiparasitic product

Therapeutic 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.

Assessment history

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