Pharmaceuticals - Community Register


Community register of veterinary medicinal products


Product information

Invented name: Apoquel   
Auth. number : EU/2/13/154
Active substance : Oclacitinib maleate
ATC: Anatomical main group: QD - Dermatologicals
Therapeutic subgroup: QD11 - Other dermatological preparations
Pharmacological subgroup: QD11A - Other dermatological preparations
Chemical subgroup: QD11AH - Agents for dermatitis, excluding corticosteroids
Chemical substance: QD11AH90 - oclacitinib
(See WHO ATCvet Index)
Indication: Target species: Dogs
Treatment of pruritus associated with allergic dermatitis in dogs.
Treatment of clinical manifestations of atopic dermatitis in dogs.
Marketing Authorisation Holder: Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
16/09/2013 Centralised - Authorisation EMEA/V/C/2688 (2013)5926 of 12/09/2013
25/10/2013 Centralised - Variation EMEA/V/C/2688/IA/1
Updated with Decision(2014)8180 of 27/10/2014
29/10/2014 Centralised - Yearly update (2014)8180 of 27/10/2014
08/05/2015 Centralised - Variation EMEA/V/C/2688/IB/6/G
Updated with Decision(2016) 3089 of 17/05/2016
19/05/2016 Centralised - Yearly update (2016) 3089 of 17/05/2016
23/03/2017 Centralised - Variation EMEA/V/C/2688/IG/747
Updated with Decision(2018)2165 of 06/04/2018
10/04/2018 Centralised - Yearly update (2018)2165 of 06/04/2018