Mirataz RSS Authorised This medicine is authorised for use in the European Union mirtazapine Medicine Veterinary Authorised
Page contentsPage contents Overview Product information Product details Authorisation details Assessment history News on Mirataz Topics 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 Mirataz : EPAR - Medicine overviewReference Number: EMA/546639/2019 English (EN) (81.94 KB - PDF)First published: 08/01/2020 Last updated: 09/10/2025 View Other languages (25) български (BG) (93.36 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View español (ES) (81.97 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View čeština (CS) (93.99 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View dansk (DA) (83.34 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View Deutsch (DE) (82.76 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View eesti keel (ET) (82.18 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View ελληνικά (EL) (93.76 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View français (FR) (82.44 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View hrvatski (HR) (92.27 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View íslenska (IS) (83.29 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View Gaeilge (GA) (83.57 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View italiano (IT) (82.29 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View latviešu valoda (LV) (94.29 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View lietuvių kalba (LT) (94.03 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View magyar (HU) (94.15 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View Malti (MT) (95.95 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View Nederlands (NL) (82.05 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View norsk (NO) (82 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View polski (PL) (95.62 KB - 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PDF) First published: 08/01/2020 Last updated: 09/10/2025 View Deutsch (DE) (81.72 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View eesti keel (ET) (81.22 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View ελληνικά (EL) (91.79 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View français (FR) (81.63 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View hrvatski (HR) (91.56 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View íslenska (IS) (81.52 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View Gaeilge (GA) (81.36 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View italiano (IT) (81.76 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View latviešu valoda (LV) (92.14 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View lietuvių kalba (LT) (92.19 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View magyar (HU) (92.76 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View Malti (MT) (93.86 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View Nederlands (NL) (81.15 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View norsk (NO) (81.52 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View polski (PL) (93.22 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View português (PT) (82.53 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View română (RO) (91.73 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View slovenčina (SK) (81.75 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View slovenščina (SL) (81.76 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View Suomi (FI) (81.11 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View svenska (SV) (81.47 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View Mirataz : EPAR - All authorised presentations English (EN) (81.94 KB - PDF)First published: 08/01/2020 Last updated: 09/10/2025 View Other languages (25) български (BG) (93.36 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View español (ES) (81.97 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View čeština (CS) (93.99 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View dansk (DA) (83.34 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View Deutsch (DE) (82.76 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View eesti keel (ET) (82.18 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View ελληνικά (EL) (93.76 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View français (FR) (82.44 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View hrvatski (HR) (92.27 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View íslenska (IS) (83.29 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View Gaeilge (GA) (83.57 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View italiano (IT) (82.29 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View latviešu valoda (LV) (94.29 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View lietuvių kalba (LT) (94.03 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View magyar (HU) (94.15 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View Malti (MT) (95.95 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View Nederlands (NL) (82.05 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View norsk (NO) (82 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View polski (PL) (95.62 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View português (PT) (83.01 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View română (RO) (94.17 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View slovenčina (SK) (94.08 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View slovenščina (SL) (82.27 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View Suomi (FI) (81.54 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View svenska (SV) (82.05 KB - PDF) First published: 08/01/2020 Last updated: 09/10/2025 View Product details Name of medicine Mirataz Active substance mirtazapine International non-proprietary name (INN) or common name mirtazapine Pharmacotherapeutic groupPsychoanalepticsAntidepressants in combination with psycholeptics Authorisation details EMA product number EMEA/V/C/004733 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Mirataz : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (81.94 KB - PDF)First published: 10/07/2020 Last updated: 09/10/2025 View Initial marketing authorisation documents Mirataz : EPAR - Public assessment reportAdopted Reference Number: EMA/562416/2019 English (EN) (81.49 KB - PDF)First published: 08/01/2020 Last updated: 09/10/2025 View CVMP summary of positive opinion for MiratazAdopted Reference Number: EMA/CVMP/515319/2019 English (EN) (69.39 KB - PDF)First published: 11/10/2019 View News on Mirataz Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-15 May 202516/05/2025 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 December 202209/12/2022 Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 10-12 May 202117/05/2021 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 October 201911/10/2019 Topics Medicines This page was last updated on 09/10/2025 Share this page