Credelio RSS Authorised This medicine is authorised for use in the European Union lotilanerMedicineVeterinaryAuthorised
Page contentsPage contents Overview Product information Product details Authorisation details Assessment history News on Credelio 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 Credelio : EPAR - Medicine overviewReference Number: EMA/122474/2017 English (EN) (81.94 KB - PDF)Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Alte limbi (25) български (BG) (93.36 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare español (ES) (81.97 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare čeština (CS) (93.99 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare dansk (DA) (83.34 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Deutsch (DE) (82.76 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare eesti (ET) (82.18 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare ελληνικά (EL) (93.76 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare français (FR) (82.44 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Gaeilge (GA) (83.57 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare hrvatski (HR) (92.27 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare italiano (IT) (82.29 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare latviešu (LV) (94.29 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare lietuvių (LT) (94.03 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare magyar (HU) (94.15 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Malti (MT) (95.95 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Nederlands (NL) (82.05 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare polski (PL) (95.62 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare português (PT) (83.01 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare română (RO) (94.17 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare slovenčina (SK) (94.08 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare slovenščina (SL) (82.27 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare suomi (FI) (81.54 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare svenska (SV) (82.05 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Íslenska (IS) (83.29 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare norsk (NO) (82 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Product information Credelio : EPAR - Product Information English (EN) (81.49 KB - PDF)Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Alte limbi (25) български (BG) (91.78 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare español (ES) (81.51 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare čeština (CS) (92.48 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare dansk (DA) (82.05 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Deutsch (DE) (81.72 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare eesti (ET) (81.22 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare ελληνικά (EL) (91.79 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare français (FR) (81.63 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Gaeilge (GA) (81.36 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare hrvatski (HR) (91.56 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare italiano (IT) (81.76 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare latviešu (LV) (92.14 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare lietuvių (LT) (92.19 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare magyar (HU) (92.76 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Malti (MT) (93.86 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Nederlands (NL) (81.15 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare polski (PL) (93.22 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare português (PT) (82.53 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare română (RO) (91.73 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare slovenčina (SK) (81.75 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare slovenščina (SL) (81.76 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare suomi (FI) (81.11 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare svenska (SV) (81.47 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Íslenska (IS) (81.52 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare norsk (NO) (81.52 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Credelio : EPAR - All Authorised presentations English (EN) (81.94 KB - PDF)Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Alte limbi (25) български (BG) (93.36 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare español (ES) (81.97 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare čeština (CS) (93.99 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare dansk (DA) (83.34 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Deutsch (DE) (82.76 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare eesti (ET) (82.18 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare ελληνικά (EL) (93.76 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare français (FR) (82.44 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Gaeilge (GA) (83.57 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare hrvatski (HR) (92.27 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare italiano (IT) (82.29 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare latviešu (LV) (94.29 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare lietuvių (LT) (94.03 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare magyar (HU) (94.15 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Malti (MT) (95.95 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Nederlands (NL) (82.05 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare polski (PL) (95.62 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare português (PT) (83.01 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare română (RO) (94.17 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare slovenčina (SK) (94.08 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare slovenščina (SL) (82.27 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare suomi (FI) (81.54 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare svenska (SV) (82.05 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Íslenska (IS) (83.29 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare norsk (NO) (82 KB - PDF) Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare Product details Name of medicine Credelio Active substance lotilaner International non-proprietary name (INN) or common name lotilaner Pharmacotherapeutic groupEctoparasiticides for systemic useIsoxazolines Authorisation details EMA product number EMEA/V/C/004247 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Credelio : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (81.94 KB - PDF)Prima publicare: 26/07/2018 Cea mai recent: 03/06/2024 Vizualizare CVMP post-authorisation summary of positive opinion for Credelio, Lotimax, Credelio PlusAdopted Reference Number: EMADOC-1700519818-2563727 English (EN) (150.22 KB - PDF)Prima publicare: 07/11/2025 Vizualizare CVMP post-authorisation summary of positive opinion for Credelio (II-0019)Adopted Reference Number: EMA/CVMP/11507/2022 English (EN) (135.26 KB - PDF)Prima publicare: 21/01/2022 Vizualizare Credelio-V-C-4247-X-0001 : EPAR - Assessment Report - ExtensionAdopted English (EN) (81.49 KB - PDF)Prima publicare: 26/07/2018 Cea mai recent: 03/06/2024 Vizualizare CVMP post-authorisation summary of positive opinion for CredelioAdopted Reference Number: EMA/CVMP/175952/2018 English (EN) (67.44 KB - PDF)Prima publicare: 20/04/2018 Cea mai recent: 20/04/2018 Vizualizare Initial marketing authorisation documents Credelio : EPAR - Public assessment reportAdopted English (EN) (81.49 KB - PDF)Prima publicare: 11/05/2017 Cea mai recent: 03/06/2024 Vizualizare CVMP summary of positive opinion for CredelioAdopted Reference Number: EMA/CVMP/49053/2017 English (EN) (68.3 KB - PDF)Prima publicare: 17/02/2017 Cea mai recent: 17/02/2017 Vizualizare News on Credelio Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 4-6 November 202507/11/2025 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) 18-19 June 202421/06/2024 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14 February 202416/02/2024 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) 18-19 January 202221/01/2022 Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 3-4 November 202108/11/2021 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 17-19 April 201820/04/2018 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 14-16 February 201717/02/2017 This page was last updated on 03/06/2024 Share this page