Profender

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emodepside / praziquantel

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

Overview

This is a summary of the European public assessment report (EPAR) for Profender. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical use on how to use Profender.

For practical information about using Profender, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

This EPAR was last updated on 14/03/2018

Authorisation details

Product details
Name
Profender
Agency product number
EMEA/V/C/000097
Active substance
  • emodepside
  • praziquantel
International non-proprietary name (INN) or common name
emodepside / praziquantel
Species
  • Dogs
  • Cats
Anatomical therapeutic chemical veterinary (ATCvet) codes
QP52AA51
Publication details
Marketing-authorisation holder
Bayer Animal Health GmbH
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
27/07/2005
Contact address
D-51368 Leverkusen
Germany

Product information

09/03/2018 Profender - EMEA/V/C/000097 - IAIN/0044

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

Therapeutic antiparasitic agent

Therapeutic indication

Cats

For cats suffering from, or at risk from, mixed parasitic infections caused by roundworms and tapeworms of the following species:

Roundworms (Nematodes)

  • Toxocara cati (mature adult, immature adult, L4 and L3);
  • Toxocara cati (L3 larvae) – treatment of queens during late pregnancy to prevent lactogenic transmission to the offspring;
  • Toxascaris leonina (mature adult, immature adult and L4);
  • Ancylostoma tubaeforme (mature adult, immature adult and L4).

Tapeworms (Cestodes)

  • Dipylidium caninum (mature adult and immature adult);
  • Taenia taeniaeformis (adult);
  • Echinococcus multilocularis (adult).

Lungworms

  • Aelurostrongylus abstrusus (adult).

Dogs

For dogs suffering from, or at risk from, mixed parasitic infections caused by roundworms and tapeworms of the following species:

Roundworms (nematodes):

  • Toxocara canis (mature adult, immature adult, L4 and L3);
  • Toxascaris leonina (mature adult, immature adult and L4);
  • Ancylostoma caninum (mature adult and immature adult);
  • Uncinaria stenocephala (mature adult and immature adult);
  • Trichuris vulpis (mature adult, immature adult and L4);

Tapeworms (Cestodes):

  • Dipylidium caninum;
  • Taenia spp.;
  • Echinococcus multilocularis (mature adult and immature);
  • Echinococcus granulosus (mature adult and immature).

Assessment history

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