Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Apoquel   
Auth. number : EU/2/13/154
INN : 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