Simparica RSS Authorised This medicine is authorised for use in the European Union sarolanerMedicineVeterinaryAuthorised
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)Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Alte limbi (25) български (BG) (93.36 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare español (ES) (81.97 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare čeština (CS) (93.99 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare dansk (DA) (83.34 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Deutsch (DE) (82.76 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare eesti (ET) (82.18 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare ελληνικά (EL) (93.76 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare français (FR) (82.44 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Gaeilge (GA) (83.57 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare hrvatski (HR) (92.27 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare italiano (IT) (82.29 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare latviešu (LV) (94.29 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare lietuvių (LT) (94.03 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare magyar (HU) (94.15 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Malti (MT) (95.95 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Nederlands (NL) (82.05 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare polski (PL) (95.62 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare português (PT) (83.01 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare română (RO) (94.17 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare slovenčina (SK) (94.08 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare slovenščina (SL) (82.27 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare suomi (FI) (81.54 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare svenska (SV) (82.05 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Íslenska (IS) (83.29 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare norsk (NO) (82 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Product information Simparica : EPAR - Product Information English (EN) (81.49 KB - PDF)Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Alte limbi (25) български (BG) (91.78 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare español (ES) (81.51 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare čeština (CS) (92.48 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare dansk (DA) (82.05 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Deutsch (DE) (81.72 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare eesti (ET) (81.22 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare ελληνικά (EL) (91.79 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare français (FR) (81.63 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Gaeilge (GA) (81.36 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare hrvatski (HR) (91.56 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare italiano (IT) (81.76 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare latviešu (LV) (92.14 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare lietuvių (LT) (92.19 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare magyar (HU) (92.76 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Malti (MT) (93.86 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Nederlands (NL) (81.15 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare polski (PL) (93.22 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare português (PT) (82.53 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare română (RO) (91.73 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare slovenčina (SK) (81.75 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare slovenščina (SL) (81.76 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare suomi (FI) (81.11 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare svenska (SV) (81.47 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Íslenska (IS) (81.52 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare norsk (NO) (81.52 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Simparica : EPAR - All Authorised presentations English (EN) (81.94 KB - PDF)Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Alte limbi (25) български (BG) (93.36 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare español (ES) (81.97 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare čeština (CS) (93.99 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare dansk (DA) (83.34 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Deutsch (DE) (82.76 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare eesti (ET) (82.18 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare ελληνικά (EL) (93.76 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare français (FR) (82.44 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Gaeilge (GA) (83.57 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare hrvatski (HR) (92.27 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare italiano (IT) (82.29 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare latviešu (LV) (94.29 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare lietuvių (LT) (94.03 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare magyar (HU) (94.15 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Malti (MT) (95.95 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Nederlands (NL) (82.05 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare polski (PL) (95.62 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare português (PT) (83.01 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare română (RO) (94.17 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare slovenčina (SK) (94.08 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare slovenščina (SL) (82.27 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare suomi (FI) (81.54 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare svenska (SV) (82.05 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare Íslenska (IS) (83.29 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare norsk (NO) (82 KB - PDF) Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare 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)Prima publicare: 26/01/2016 Cea mai recent: 11/06/2024 Vizualizare CVMP post-authorisation summary of positive opinion for Simparica (WS)Adopted Reference Number: EMA/CVMP/780812/2022 English (EN) (145.03 KB - PDF)Prima publicare: 07/10/2022 Vizualizare Simparica-V-C-3991-II-0006: EPAR - Assessment Report - VariationAdopted English (EN) (81.49 KB - PDF)Prima publicare: 08/12/2017 Cea mai recent: 11/06/2024 Vizualizare CVMP post-authorisation summary of positive opinion for SimparicaReference Number: EMA/CVMP/557544/2017 English (EN) (67.3 KB - PDF)Prima publicare: 08/09/2017 Cea mai recent: 08/09/2017 Vizualizare Initial marketing authorisation documents Simparica : EPAR - Public assessment reportAdopted English (EN) (81.49 KB - PDF)Prima publicare: 18/12/2015 Cea mai recent: 11/06/2024 Vizualizare CVMP summary of positive opinion for SimparicaAdopted Reference Number: EMA/CVMP/478463/2015 English (EN) (68.99 KB - PDF)Prima publicare: 11/09/2015 Cea mai recent: 15/09/2015 Vizualizare 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