Simparica RSS Authorised This medicine is authorised for use in the European Union sarolaner Medicine Veterinary Authorised
Page contentsPage contents Overview Product information Product details Authorisation details Assessment history News on Simparica 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 Simparica : EPAR - Summary for the public English (EN) (81.94 KB - PDF)First published: 18/12/2015 Last updated: 11/06/2024 View Other languages (25) български (BG) (93.36 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View español (ES) (81.97 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View čeština (CS) (93.99 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View dansk (DA) (83.34 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View Deutsch (DE) (82.76 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View eesti keel (ET) (82.18 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View ελληνικά (EL) (93.76 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View français (FR) (82.44 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View hrvatski (HR) (92.27 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View íslenska (IS) (83.29 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View Gaeilge (GA) (83.57 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View italiano (IT) (82.29 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View latviešu valoda (LV) (94.29 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View lietuvių kalba (LT) (94.03 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View magyar (HU) (94.15 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View Malti (MT) (95.95 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View Nederlands (NL) (82.05 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View norsk (NO) (82 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View polski (PL) (95.62 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View português (PT) (83.01 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View română (RO) (94.17 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View slovenčina (SK) (94.08 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View slovenščina (SL) (82.27 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View Suomi (FI) (81.54 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View svenska (SV) (82.05 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View Product information Simparica : EPAR - Product Information English (EN) (81.49 KB - PDF)First published: 18/12/2015 Last updated: 11/06/2024 View Other languages (25) български (BG) (91.78 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View español (ES) (81.51 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View čeština (CS) (92.48 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View dansk (DA) (82.05 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View Deutsch (DE) (81.72 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View eesti keel (ET) (81.22 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View ελληνικά (EL) (91.79 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View français (FR) (81.63 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View hrvatski (HR) (91.56 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View íslenska (IS) (81.52 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View Gaeilge (GA) (81.36 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View italiano (IT) (81.76 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View latviešu valoda (LV) (92.14 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View lietuvių kalba (LT) (92.19 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View magyar (HU) (92.76 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View Malti (MT) (93.86 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View Nederlands (NL) (81.15 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View norsk (NO) (81.52 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View polski (PL) (93.22 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View português (PT) (82.53 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View română (RO) (91.73 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View slovenčina (SK) (81.75 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View slovenščina (SL) (81.76 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View Suomi (FI) (81.11 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View svenska (SV) (81.47 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View Simparica : EPAR - All Authorised presentations English (EN) (81.94 KB - PDF)First published: 18/12/2015 Last updated: 11/06/2024 View Other languages (25) български (BG) (93.36 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View español (ES) (81.97 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View čeština (CS) (93.99 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View dansk (DA) (83.34 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View Deutsch (DE) (82.76 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View eesti keel (ET) (82.18 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View ελληνικά (EL) (93.76 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View français (FR) (82.44 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View hrvatski (HR) (92.27 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View íslenska (IS) (83.29 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View Gaeilge (GA) (83.57 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View italiano (IT) (82.29 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View latviešu valoda (LV) (94.29 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View lietuvių kalba (LT) (94.03 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View magyar (HU) (94.15 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View Malti (MT) (95.95 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View Nederlands (NL) (82.05 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View norsk (NO) (82 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View polski (PL) (95.62 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View português (PT) (83.01 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View română (RO) (94.17 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View slovenčina (SK) (94.08 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View slovenščina (SL) (82.27 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View Suomi (FI) (81.54 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View svenska (SV) (82.05 KB - PDF) First published: 18/12/2015 Last updated: 11/06/2024 View Product details Name of medicine Simparica Active substance sarolaner International non-proprietary name (INN) or common name sarolaner Pharmacotherapeutic groupEctoparasiticides for systemic use Authorisation details EMA product number EMEA/V/C/003991 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Simparica : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (81.94 KB - PDF)First published: 26/01/2016 Last updated: 11/06/2024 View CVMP post-authorisation summary of positive opinion for Simparica (WS)Adopted Reference Number: EMA/CVMP/780812/2022 English (EN) (145.03 KB - PDF)First published: 07/10/2022 View Simparica-V-C-3991-II-0006: EPAR - Assessment Report - VariationAdopted English (EN) (81.49 KB - PDF)First published: 08/12/2017 Last updated: 11/06/2024 View CVMP post-authorisation summary of positive opinion for SimparicaReference Number: EMA/CVMP/557544/2017 English (EN) (67.3 KB - PDF)First published: 08/09/2017 Last updated: 08/09/2017 View Initial marketing authorisation documents Simparica : EPAR - Public assessment reportAdopted English (EN) (81.49 KB - PDF)First published: 18/12/2015 Last updated: 11/06/2024 View CVMP summary of positive opinion for SimparicaAdopted Reference Number: EMA/CVMP/478463/2015 English (EN) (68.99 KB - PDF)First published: 11/09/2015 Last updated: 15/09/2015 View News on Simparica Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 September 202413/09/2024 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 7-9 November 202310/11/2023 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 October 202306/10/2023 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 5-7 September 202308/09/2023 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 May 202322/05/2023 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 4-6 October 202207/10/2022 Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 7-9 December 202110/12/2021 Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 6-7 October 202009/10/2020 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 June 202019/06/2020 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 21-22 May 201924/05/2019 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19-21 March 201922/03/2019 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5–7 September 201708/09/2017 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 May 201715/05/2017 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 October 201607/10/2016 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 September 201511/09/2015 This page was last updated on 11/06/2024 Share this page