NexGard RSS Authorised This medicine is authorised for use in the European Union afoxolanerMedicineVeterinaryAuthorised
Page contentsPage contents Overview Product information Product details Authorisation details Assessment history News on NexGard 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 NexGard : EPAR - Medicine overview English (EN) (81.94 KB - PDF)Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Alte limbi (25) български (BG) (93.36 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare español (ES) (81.97 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare čeština (CS) (93.99 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare dansk (DA) (83.34 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Deutsch (DE) (82.76 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare eesti (ET) (82.18 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare ελληνικά (EL) (93.76 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare français (FR) (82.44 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Gaeilge (GA) (83.57 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare hrvatski (HR) (92.27 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare italiano (IT) (82.29 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare latviešu (LV) (94.29 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare lietuvių (LT) (94.03 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare magyar (HU) (94.15 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Malti (MT) (95.95 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Nederlands (NL) (82.05 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare polski (PL) (95.62 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare português (PT) (83.01 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare română (RO) (94.17 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare slovenčina (SK) (94.08 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare slovenščina (SL) (82.27 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare suomi (FI) (81.54 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare svenska (SV) (82.05 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Íslenska (IS) (83.29 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare norsk (NO) (82 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Product information NexGard : EPAR - Product Information English (EN) (81.49 KB - PDF)Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Alte limbi (25) български (BG) (91.78 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare español (ES) (81.51 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare čeština (CS) (92.48 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare dansk (DA) (82.05 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Deutsch (DE) (81.72 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare eesti (ET) (81.22 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare ελληνικά (EL) (91.79 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare français (FR) (81.63 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Gaeilge (GA) (81.36 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare hrvatski (HR) (91.56 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare italiano (IT) (81.76 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare latviešu (LV) (92.14 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare lietuvių (LT) (92.19 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare magyar (HU) (92.76 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Malti (MT) (93.86 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Nederlands (NL) (81.15 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare polski (PL) (93.22 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare português (PT) (82.53 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare română (RO) (91.73 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare slovenčina (SK) (81.75 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare slovenščina (SL) (81.76 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare suomi (FI) (81.11 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare svenska (SV) (81.47 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Íslenska (IS) (81.52 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare norsk (NO) (81.52 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare NexGard : EPAR - All Authorised presentations English (EN) (81.94 KB - PDF)Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Alte limbi (25) български (BG) (93.36 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare español (ES) (81.97 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare čeština (CS) (93.99 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare dansk (DA) (83.34 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Deutsch (DE) (82.76 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare eesti (ET) (82.18 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare ελληνικά (EL) (93.76 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare français (FR) (82.44 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Gaeilge (GA) (83.57 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare hrvatski (HR) (92.27 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare italiano (IT) (82.29 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare latviešu (LV) (94.29 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare lietuvių (LT) (94.03 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare magyar (HU) (94.15 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Malti (MT) (95.95 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Nederlands (NL) (82.05 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare polski (PL) (95.62 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare português (PT) (83.01 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare română (RO) (94.17 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare slovenčina (SK) (94.08 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare slovenščina (SL) (82.27 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare suomi (FI) (81.54 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare svenska (SV) (82.05 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Íslenska (IS) (83.29 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare norsk (NO) (82 KB - PDF) Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare Product details Name of medicine NexGard Active substance afoxolaner International non-proprietary name (INN) or common name afoxolaner Pharmacotherapeutic groupIsoxazolinesEctoparasiticides for systemic use Authorisation details EMA product number EMEA/V/C/002729 Assessment history Expand section Collapse section Changes since initial authorisation of medicine NexGard : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (81.94 KB - PDF)Prima publicare: 17/09/2014 Cea mai recent: 13/06/2024 Vizualizare CVMP post-authorisation summary of positive opinion for NexGard (VRA0000245082)Adopted Reference Number: EMADOC-1700519818-2201538 English (EN) (149.54 KB - PDF)Prima publicare: 13/06/2025 Vizualizare CVMP post-authorisation summary of positive opinion for NexGard (WS)Adopted Reference Number: EMA/CVMP/924541/2022 English (EN) (147.37 KB - PDF)Prima publicare: 09/12/2022 Vizualizare NexGard-V-C-WS-1559 : EPAR - Assessment report - VariationAdopted English (EN) (81.49 KB - PDF)Prima publicare: 07/10/2019 Cea mai recent: 13/06/2024 Vizualizare CVMP post-authorisation summary of positive opinion for NexGard Spectra ; NexGardAdopted Reference Number: EMA/CVMP/369028/2019 English (EN) (113.4 KB - PDF)Prima publicare: 19/07/2019 Vizualizare NexGard-V-C-2729-WS-1338-G : EPAR - Assessment Report - VariationAdopted English (EN) (81.49 KB - PDF)Prima publicare: 10/12/2018 Cea mai recent: 13/06/2024 Vizualizare CVMP post-authorisation summary of positive opinion for NexGard (WS1338_G)Adopted Reference Number: EMA/CVMP/525858/2018 English (EN) (70.42 KB - PDF)Prima publicare: 14/09/2018 Cea mai recent: 14/09/2018 Vizualizare Initial marketing authorisation documents CVMP summary of positive opinion for NexGardAdopted Reference Number: EMA/CVMP/700673/2013 English (EN) (68.52 KB - PDF)Prima publicare: 13/12/2013 Cea mai recent: 13/12/2013 Vizualizare NexGard : EPAR - Public assessment reportAdopted English (EN) (81.49 KB - PDF)Prima publicare: 27/03/2013 Cea mai recent: 13/06/2024 Vizualizare News on NexGard Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 2-4 December 202505/12/2025 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) 16-18 April 202419/04/2024 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 December 202209/12/2022 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 12-14 July 202215/07/2022 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) 8-9 September 202011/09/2020 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 July 201919/07/2019 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19-21 February 201922/02/2019 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 11-13 September 201814/09/2018 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 March 201816/03/2018 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 April 201718/04/2017 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 12-14 July 201615/07/2016 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 September 201511/09/2015 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 10-12 March 201513/03/2015 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 February 201513/02/2015 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 December 201313/12/2013 This page was last updated on 02/09/2025 Share this page