Bravecto RSS Authorised This medicine is authorised for use in the European Union fluralaner Medicine Veterinary Authorised
Page contentsPage contents Overview Product information Product details Authorisation details Assessment history News on Bravecto More information on Bravecto More information on Bravecto 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 Bravecto : EPAR - Medicine overviewReference Number: EMA/783442/2014 English (EN) (81.94 KB - PDF)First published: 26/03/2014 Last updated: 03/06/2024 View Other languages (25) български (BG) (93.36 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View español (ES) (81.97 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View čeština (CS) (93.99 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View dansk (DA) (83.34 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View Deutsch (DE) (82.76 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View eesti keel (ET) (82.18 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View ελληνικά (EL) (93.76 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View français (FR) (82.44 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View hrvatski (HR) (92.27 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View íslenska (IS) (83.29 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View Gaeilge (GA) (83.57 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View italiano (IT) (82.29 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View latviešu valoda (LV) (94.29 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View lietuvių kalba (LT) (94.03 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View magyar (HU) (94.15 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View Malti (MT) (95.95 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View Nederlands (NL) (82.05 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View norsk (NO) (82 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View polski (PL) (95.62 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View português (PT) (83.01 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View română (RO) (94.17 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View slovenčina (SK) (94.08 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View slovenščina (SL) (82.27 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View Suomi (FI) (81.54 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View svenska (SV) (82.05 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View Product information Bravecto : EPAR - Product Information English (EN) (81.49 KB - PDF)First published: 26/03/2014 Last updated: 03/06/2024 View Other languages (25) български (BG) (91.78 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View español (ES) (81.51 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View čeština (CS) (92.48 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View dansk (DA) (82.05 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View Deutsch (DE) (81.72 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View eesti keel (ET) (81.22 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View ελληνικά (EL) (91.79 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View français (FR) (81.63 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View hrvatski (HR) (91.56 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View íslenska (IS) (81.52 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View Gaeilge (GA) (81.36 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View italiano (IT) (81.76 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View latviešu valoda (LV) (92.14 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View lietuvių kalba (LT) (92.19 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View magyar (HU) (92.76 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View Malti (MT) (93.86 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View Nederlands (NL) (81.15 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View norsk (NO) (81.52 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View polski (PL) (93.22 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View português (PT) (82.53 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View română (RO) (91.73 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View slovenčina (SK) (81.75 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View slovenščina (SL) (81.76 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View Suomi (FI) (81.11 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View svenska (SV) (81.47 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View Bravecto : EPAR - All Authorised presentations English (EN) (81.94 KB - PDF)First published: 26/03/2014 Last updated: 03/06/2024 View Other languages (25) български (BG) (93.36 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View español (ES) (81.97 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View čeština (CS) (93.99 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View dansk (DA) (83.34 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View Deutsch (DE) (82.76 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View eesti keel (ET) (82.18 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View ελληνικά (EL) (93.76 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View français (FR) (82.44 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View hrvatski (HR) (92.27 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View íslenska (IS) (83.29 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View Gaeilge (GA) (83.57 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View italiano (IT) (82.29 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View latviešu valoda (LV) (94.29 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View lietuvių kalba (LT) (94.03 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View magyar (HU) (94.15 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View Malti (MT) (95.95 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View Nederlands (NL) (82.05 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View norsk (NO) (82 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View polski (PL) (95.62 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View português (PT) (83.01 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View română (RO) (94.17 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View slovenčina (SK) (94.08 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View slovenščina (SL) (82.27 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View Suomi (FI) (81.54 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View svenska (SV) (82.05 KB - PDF) First published: 26/03/2014 Last updated: 03/06/2024 View Product details Name of medicine Bravecto Active substance fluralaner International non-proprietary name (INN) or common name fluralaner Pharmacotherapeutic groupEctoparasiticides for systemic useIsoxazolines Authorisation details EMA product number EMEA/V/C/002526 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Bravecto : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (81.94 KB - PDF)First published: 30/09/2015 Last updated: 03/06/2024 View CVMP post-authorisation summary of positive opinion for Bravecto (VRA-0059) English (EN) (125.96 KB - PDF)First published: 11/12/2023 View CVMP post-authorisation summary of positive opinion for Bravecto (II-0054-G)Adopted Reference Number: EMA/CVMP/294601/2022 English (EN) (127.86 KB - PDF)First published: 17/06/2022 View Bravecto-V-C-2526-II-0051 : EPAR - Assessment Report - VariationAdopted English (EN) (81.49 KB - PDF)First published: 21/03/2022 Last updated: 03/06/2024 View CVMP post-authorisation summary of positive opinion for Bravecto (II-0051)Adopted Reference Number: EMA/CVMP/696735/2021 English (EN) (140.68 KB - PDF)First published: 10/12/2021 View Bravecto-V-C-2526-II-0036 : EPAR - Assessment Report - VariationAdopted English (EN) (81.49 KB - PDF)First published: 19/11/2019 Last updated: 03/06/2024 View Bravecto-V-C-2526-II-0033-G : EPAR - Assessment Report - VariationAdopted English (EN) (81.49 KB - PDF)First published: 19/11/2019 Last updated: 03/06/2024 View CVMP post-authorisation summary of positive opinion for Bravecto (II/0033/G, II/0036)Adopted Reference Number: EMA/CVMP/465180/2019 English (EN) (149.32 KB - PDF)First published: 13/09/2019 View Bravecto-V-C-2526-X-0005 : EPAR - Assessment Report - VariationAdopted English (EN) (81.49 KB - PDF)First published: 22/06/2016 Last updated: 03/06/2024 View CVMP post-authorisation summary of positive opinion for BravectoAdopted Reference Number: EMA/CVMP/186144/2016 English (EN) (68.13 KB - PDF)First published: 18/03/2016 Last updated: 18/03/2016 View Initial marketing authorisation documents Bravecto : EPAR - Public assessment reportAdopted English (EN) (81.49 KB - PDF)First published: 26/03/2014 Last updated: 03/06/2024 View CVMP summary of positive opinion for BravectoAdopted Reference Number: EMA/CVMP/627638/2013 English (EN) (75.03 KB - PDF)First published: 13/12/2013 Last updated: 13/12/2013 View News on Bravecto Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 June 202513/06/2025 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 March 202514/03/2025 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 March 202324/03/2023 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 March 202324/03/2023 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-15 June 202217/06/2022 Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 7-9 December 202110/12/2021 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-23 April 202024/04/2020 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 February 202021/02/2020 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-23 January 202024/01/2020 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 5-7 November 201908/11/2019 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 October 201911/10/2019 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 9-11 October 201812/10/2018 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 March 201816/03/2018 Tick and flea control agent Bravecto continues to be acceptably safe to use17/08/2017 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 14-16 March 201717/03/2017 Release of documents on two medicines temporarily halted14/03/2017 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 6-8 September 201609/09/2016 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 15-17 March 201618/03/2016 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 16-18 February 201619/02/2016 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 19-21 January 201622/01/2016 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 December 201511/12/2015 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 7-9 July 201510/07/2015 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 January 201516/01/2015 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 December 201313/12/2013 More information on Bravecto Responses to questions raised at the Bravecto petition hand over English (EN) (220.48 KB - PDF)First published: 08/11/2019 View More information on Bravecto Bravecto - withdrawal of application for variation to marketing authorisation Topics Medicines This page was last updated on 03/06/2024 Share this page