Sileo
dexmedetomidine
Table of contents
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).
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 |
8
|
Date of issue of marketing authorisation valid throughout the European Union |
10/06/2015
|
Contact address |
Orionintie 1
02 200 Espoo Finland |
Product information
08/01/2021 Sileo - EMEA/V/C/003764 - IAIN/0019
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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Nervous system
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Other hypnotics and sedatives
Therapeutic indication
Alleviation of acute anxiety and fear associated with noise in dogs.