Osurnia RSS Authorised This medicine is authorised for use in the European Union terbinafine / florfenicol / betamethasone Medicine Veterinary Authorised
Page contentsPage contents Overview Product information Product details Authorisation details Assessment history News on Osurnia 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 Osurnia : EPAR - Summary for the public English (EN) (81.94 KB - PDF)First published: 15/08/2014 Last updated: 09/10/2025 View Other languages (25) български (BG) (93.36 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View español (ES) (81.97 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View čeština (CS) (93.99 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View dansk (DA) (83.34 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View Deutsch (DE) (82.76 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View eesti keel (ET) (82.18 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View ελληνικά (EL) (93.76 KB - 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PDF) First published: 15/08/2014 Last updated: 09/10/2025 View Deutsch (DE) (81.72 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View eesti keel (ET) (81.22 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View ελληνικά (EL) (91.79 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View français (FR) (81.63 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View hrvatski (HR) (91.56 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View íslenska (IS) (81.52 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View Gaeilge (GA) (81.36 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View italiano (IT) (81.76 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View latviešu valoda (LV) (92.14 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View lietuvių kalba (LT) (92.19 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View magyar (HU) (92.76 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View Malti (MT) (93.86 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View Nederlands (NL) (81.15 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View norsk (NO) (81.52 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View polski (PL) (93.22 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View português (PT) (82.53 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View română (RO) (91.73 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View slovenčina (SK) (81.75 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View slovenščina (SL) (81.76 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View Suomi (FI) (81.11 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View svenska (SV) (81.47 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View Osurnia : EPAR - All Authorised presentations English (EN) (81.94 KB - PDF)First published: 15/08/2014 Last updated: 09/10/2025 View Other languages (25) български (BG) (93.36 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View español (ES) (81.97 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View čeština (CS) (93.99 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View dansk (DA) (83.34 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View Deutsch (DE) (82.76 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View eesti keel (ET) (82.18 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View ελληνικά (EL) (93.76 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View français (FR) (82.44 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View hrvatski (HR) (92.27 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View íslenska (IS) (83.29 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View Gaeilge (GA) (83.57 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View italiano (IT) (82.29 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View latviešu valoda (LV) (94.29 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View lietuvių kalba (LT) (94.03 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View magyar (HU) (94.15 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View Malti (MT) (95.95 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View Nederlands (NL) (82.05 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View norsk (NO) (82 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View polski (PL) (95.62 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View português (PT) (83.01 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View română (RO) (94.17 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View slovenčina (SK) (94.08 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View slovenščina (SL) (82.27 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View Suomi (FI) (81.54 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View svenska (SV) (82.05 KB - PDF) First published: 15/08/2014 Last updated: 09/10/2025 View Product details Name of medicine Osurnia Active substance betamethasone acetateterbinafineflorfenicol International non-proprietary name (INN) or common name terbinafineflorfenicolbetamethasone Pharmacotherapeutic groupCorticosteroids and antiinfectives in combination Authorisation details EMA product number EMEA/V/C/003753 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Osurnia : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (81.94 KB - PDF)First published: 04/08/2015 Last updated: 09/10/2025 View Initial marketing authorisation documents Osurnia : EPAR - Public assessment report English (EN) (81.49 KB - PDF)First published: 15/08/2014 Last updated: 09/10/2025 View CVMP summary of positive opinion for OsurniaAdopted Reference Number: EMA/CVMP/290192/2014 English (EN) (95.74 KB - PDF)First published: 06/06/2014 Last updated: 06/06/2014 View News on Osurnia Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 9-10 September 202512/09/2025 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 March 202514/03/2025 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 5-7 November 201908/11/2019 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 September 201913/09/2019 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 15-16 April 201923/04/2019 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 September 201814/09/2018 Eye injuries in people and dogs when using Osurnia ear gel for dogs20/04/2018 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5–7 December 201708/12/2017 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 July 201714/07/2017 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 17-19 January 201720/01/2017 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 3-5 June 201406/06/2014 Topics Medicines This page was last updated on 09/10/2025 Share this page