Cepedex

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dexmedetomidine

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

Overview

This is a summary of the European public assessment report (EPAR) for Cepedex. 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 advice on how to use Cepedex.

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

This EPAR was last updated on 16/10/2018

Authorisation details

Product details
Name
Cepedex
Agency product number
EMEA/V/C/004376
Active substance
dexmedetomidine hydrochloride
International non-proprietary name (INN) or common name
dexmedetomidine
Species
  • Cats
  • Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QN05CM18
Publication details
Marketing-authorisation holder
CP-Pharma Handelsgesellschaft mbH
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
12/12/2016
Contact address
Ostlandring 13
31303 Burgdorf
Germany

Product information

18/09/2018 Cepedex - EMEA/V/C/004376 - IB/0003

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

  • PSYCHOLEPTICS
  • HYPNOTICS AND SEDATIVES

Therapeutic indication

Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.

Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.

Premedication in dogs and cats before induction and maintenance of general anaesthesia.

Assessment history

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