Kexxtone

RSS

monensin

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

Overview

This is a summary of the European Public Assessment Report. 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 05/10/2018

Authorisation details

Product details
Name
Kexxtone
Agency product number
EMEA/V/C/002235
Active substance
monensin (as monensin sodium)
International non-proprietary name (INN) or common name
monensin
Species
Cattle (cows and heifers)
Anatomical therapeutic chemical veterinary (ATCvet) codes
QA16QA06
Publication details
Marketing-authorisation holder
Elanco GmbH
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
28/01/2013
Contact address

Heinz-Lohmann-Str. 4
27472 Cuxhaven
Germany

Product information

24/09/2018 Kexxtone - EMEA/V/C/002235 - T/0010

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

Drugs used to treat acetonaemia

Therapeutic indication

For the reduction in the incidence of ketosis in the peri-parturient dairy cow/heifer which is expected to develop ketosis.

Assessment history

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