Stelfonta RSS Authorised This medicine is authorised for use in the European Union tigilanol tiglate Medicine Veterinary Authorised
Page contentsPage contents Overview Product information Product details Authorisation details Assessment history News on Stelfonta 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 Stelfonta : EPAR - Medicine overview English (EN) (81.94 KB - PDF)First published: 11/02/2020 Last updated: 14/10/2025 View Other languages (25) български (BG) (93.36 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View español (ES) (81.97 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View čeština (CS) (93.99 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View dansk (DA) (83.34 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View Deutsch (DE) (82.76 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View eesti keel (ET) (82.18 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View ελληνικά (EL) (93.76 KB - 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PDF) First published: 11/02/2020 Last updated: 14/10/2025 View Deutsch (DE) (81.72 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View eesti keel (ET) (81.22 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View ελληνικά (EL) (91.79 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View français (FR) (81.63 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View hrvatski (HR) (91.56 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View íslenska (IS) (81.52 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View Gaeilge (GA) (81.36 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View italiano (IT) (81.76 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View latviešu valoda (LV) (92.14 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View lietuvių kalba (LT) (92.19 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View magyar (HU) (92.76 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View Malti (MT) (93.86 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View Nederlands (NL) (81.15 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View norsk (NO) (81.52 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View polski (PL) (93.22 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View português (PT) (82.53 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View română (RO) (91.73 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View slovenčina (SK) (81.75 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View slovenščina (SL) (81.76 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View Suomi (FI) (81.11 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View svenska (SV) (81.47 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View Latest procedure affecting product information: Stelfonta : EPAR - All authorised presentations English (EN) (81.94 KB - PDF)First published: 11/02/2020 Last updated: 14/10/2025 View Other languages (25) български (BG) (93.36 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View español (ES) (81.97 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View čeština (CS) (93.99 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View dansk (DA) (83.34 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View Deutsch (DE) (82.76 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View eesti keel (ET) (82.18 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View ελληνικά (EL) (93.76 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View français (FR) (82.44 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View hrvatski (HR) (92.27 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View íslenska (IS) (83.29 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View Gaeilge (GA) (83.57 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View italiano (IT) (82.29 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View latviešu valoda (LV) (94.29 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View lietuvių kalba (LT) (94.03 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View magyar (HU) (94.15 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View Malti (MT) (95.95 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View Nederlands (NL) (82.05 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View norsk (NO) (82 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View polski (PL) (95.62 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View português (PT) (83.01 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View română (RO) (94.17 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View slovenčina (SK) (94.08 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View slovenščina (SL) (82.27 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View Suomi (FI) (81.54 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View svenska (SV) (82.05 KB - PDF) First published: 11/02/2020 Last updated: 14/10/2025 View Product details Name of medicine Stelfonta Active substance tigilanol tiglate International non-proprietary name (INN) or common name tigilanol tiglate Pharmacotherapeutic grouptigilanol tiglate Authorisation details EMA product number EMEA/V/C/005018 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Stelfonta : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (81.94 KB - PDF)First published: 13/05/2020 Last updated: 14/10/2025 View Initial marketing authorisation documents Stelfonta : EPAR - Public assessment reportAdopted English (EN) (81.49 KB - PDF)First published: 11/02/2020 Last updated: 14/10/2025 View CVMP summary of positive opinion for StelfontaAdopted Reference Number: EMA/CVMP/560649/2019 English (EN) (139.25 KB - PDF)First published: 08/11/2019 View News on Stelfonta Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 5-7 September 202308/09/2023 Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 18-19 January 202221/01/2022 Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 13-15 July 202116/07/2021 Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 19-20 January 202122/01/2021 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5-7 November 201908/11/2019 Topics Medicines This page was last updated on 14/10/2025 Share this page