Apoquel
oclacitinib maleate
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 |
Apoquel
|
Agency product number |
EMEA/V/C/002688
|
Active substance |
oclacitinib maleate
|
International non-proprietary name (INN) or common name |
oclacitinib maleate
|
Species |
Dogs
|
Anatomical therapeutic chemical veterinary (ATCvet) codes |
QD11AH90
|
Publication details | |
---|---|
Marketing-authorisation holder |
Zoetis Belgium SA
|
Revision |
6
|
Date of issue of marketing authorisation valid throughout the European Union |
12/09/2013
|
Contact address |
Product information
05/12/2019 Apoquel - EMEA/V/C/002688 - II/0017/G
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 indication
Treatment of clinical manifestations of Pruritus associated with Allergic Dermatitis in dogs.
Treatment of clinical manifestations of Atopic Dermatitis in dogs.