Sileo

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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. 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 14/08/2018

Authorisation details

Product details
Name
Sileo
Agency product number
EMEA/V/C/003764
Active substance
dexmedetomidine hydrochloride
International non-proprietary name (INN) or common name
dexmedetomidine
Species
Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QN05CM18
Publication details
Marketing-authorisation holder
Orion Corporation
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
10/06/2015
Contact address
Orionintie 1
02 200 Espoo
Finland

Product information

09/08/2018 Sileo - EMEA/V/C/003764 - IA/0009

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

  • NERVOUS SYSTEM
  • Other hypnotics and sedatives

Therapeutic indication

Alleviation of acute anxiety and fear associated with noise in dogs.

Assessment history

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