Apoquel RSS Authorised This medicine is authorised for use in the European Union oclacitinib maleateMedicineVeterinaryAuthorised
Page contentsPage contents Overview Product information Product details Authorisation details Assessment history News on Apoquel Domenii de activitate Application under evaluation CVMP opinion European Commission decision OverviewUp-to-date information on this veterinary medicinal product is available on the Veterinary Medicines Information website Apoquel : EPAR - Summary for the public English (EN) (81.94 KB - PDF)Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Alte limbi (25) български (BG) (93.36 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare español (ES) (81.97 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare čeština (CS) (93.99 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare dansk (DA) (83.34 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Deutsch (DE) (82.76 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare eesti (ET) (82.18 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare ελληνικά (EL) (93.76 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare français (FR) (82.44 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Gaeilge (GA) (83.57 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare hrvatski (HR) (92.27 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare italiano (IT) (82.29 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare latviešu (LV) (94.29 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare lietuvių (LT) (94.03 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare magyar (HU) (94.15 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Malti (MT) (95.95 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Nederlands (NL) (82.05 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare polski (PL) (95.62 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare português (PT) (83.01 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare română (RO) (94.17 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare slovenčina (SK) (94.08 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare slovenščina (SL) (82.27 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare suomi (FI) (81.54 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare svenska (SV) (82.05 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Íslenska (IS) (83.29 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare norsk (NO) (82 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Product information Apoquel : EPAR - Product Information English (EN) (81.49 KB - PDF)Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Alte limbi (25) български (BG) (91.78 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare español (ES) (81.51 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare čeština (CS) (92.48 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare dansk (DA) (82.05 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Deutsch (DE) (81.72 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare eesti (ET) (81.22 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare ελληνικά (EL) (91.79 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare français (FR) (81.63 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Gaeilge (GA) (81.36 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare hrvatski (HR) (91.56 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare italiano (IT) (81.76 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare latviešu (LV) (92.14 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare lietuvių (LT) (92.19 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare magyar (HU) (92.76 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Malti (MT) (93.86 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Nederlands (NL) (81.15 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare polski (PL) (93.22 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare português (PT) (82.53 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare română (RO) (91.73 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare slovenčina (SK) (81.75 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare slovenščina (SL) (81.76 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare suomi (FI) (81.11 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare svenska (SV) (81.47 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Íslenska (IS) (81.52 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare norsk (NO) (81.52 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Apoquel : EPAR - All Authorised presentations English (EN) (81.94 KB - PDF)Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Alte limbi (25) български (BG) (93.36 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare español (ES) (81.97 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare čeština (CS) (93.99 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare dansk (DA) (83.34 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Deutsch (DE) (82.76 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare eesti (ET) (82.18 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare ελληνικά (EL) (93.76 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare français (FR) (82.44 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Gaeilge (GA) (83.57 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare hrvatski (HR) (92.27 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare italiano (IT) (82.29 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare latviešu (LV) (94.29 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare lietuvių (LT) (94.03 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare magyar (HU) (94.15 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Malti (MT) (95.95 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Nederlands (NL) (82.05 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare polski (PL) (95.62 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare português (PT) (83.01 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare română (RO) (94.17 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare slovenčina (SK) (94.08 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare slovenščina (SL) (82.27 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare suomi (FI) (81.54 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare svenska (SV) (82.05 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Íslenska (IS) (83.29 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare norsk (NO) (82 KB - PDF) Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare Product details Name of medicine Apoquel Active substance oclacitinib maleate International non-proprietary name (INN) or common name oclacitinib maleate Pharmacotherapeutic groupAgents for dermatitis, excluding corticosteroids Authorisation details EMA product number EMEA/V/C/002688 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Apoquel : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (81.94 KB - PDF)Prima publicare: 08/01/2014 Cea mai recent: 25/06/2024 Vizualizare Apoquel-V-C-002688-X-0019 : EPAR - Assessment report - VariationAdopted English (EN) (81.49 KB - PDF)Prima publicare: 21/01/2022 Cea mai recent: 25/06/2024 Vizualizare CVMP post-authorisation summary of positive opinion for Apoquel (II-0019)Adopted Reference Number: EMA/CVMP/523501/2021 English (EN) (115.97 KB - PDF)Prima publicare: 08/10/2021 Vizualizare Initial marketing authorisation documents Apoquel : EPAR - Public assessment reportAdopted English (EN) (81.49 KB - PDF)Prima publicare: 15/10/2013 Cea mai recent: 25/06/2024 Vizualizare CVMP summary of positive opinion for ApoquelAdopted Reference Number: EMA/CVMP/322909/2013 English (EN) (68.11 KB - PDF)Prima publicare: 19/07/2013 Cea mai recent: 19/07/2013 Vizualizare News on Apoquel Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 July 202314/07/2023 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 November 202211/11/2022 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 May 202213/05/2022 Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 5-7 October 202108/10/2021 Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 13-15 July 202116/07/2021 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 3-5 December 201906/12/2019 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 23–25 May 201828/05/2018 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 October 201607/10/2016 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 19-21 April 201622/04/2016 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 6-8 October 201509/10/2015 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 April 201513/04/2015 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 7-9 October 201410/10/2014 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 April 201411/04/2014 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 July 201319/07/2013 Domenii de activitate Medicines This page was last updated on 25/06/2024 Share this page