Syvazul BTV RSS Authorised This medicine is authorised for use in the European Union bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3) Medicine Veterinary Authorised
Page contentsPage contents Overview Product information Product details Authorisation details Assessment history News on Syvazul BTV 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 Syvazul BTV : EPAR - Medicine overview English (EN) (81.94 KB - PDF)First published: 08/02/2019 Last updated: 02/09/2025 View Other languages (25) български (BG) (93.36 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View español (ES) (81.97 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View čeština (CS) (93.99 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View dansk (DA) (83.34 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View Deutsch (DE) (82.76 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View eesti keel (ET) (82.18 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View ελληνικά (EL) (93.76 KB - 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PDF) First published: 08/02/2019 Last updated: 02/09/2025 View Deutsch (DE) (81.72 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View eesti keel (ET) (81.22 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View ελληνικά (EL) (91.79 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View français (FR) (81.63 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View hrvatski (HR) (91.56 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View íslenska (IS) (81.52 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View Gaeilge (GA) (81.36 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View italiano (IT) (81.76 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View latviešu valoda (LV) (92.14 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View lietuvių kalba (LT) (92.19 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View magyar (HU) (92.76 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View Malti (MT) (93.86 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View Nederlands (NL) (81.15 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View norsk (NO) (81.52 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View polski (PL) (93.22 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View português (PT) (82.53 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View română (RO) (91.73 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View slovenčina (SK) (81.75 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View slovenščina (SL) (81.76 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View Suomi (FI) (81.11 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View svenska (SV) (81.47 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View Syvazul BTV : EPAR - All authorised presentations English (EN) (81.94 KB - PDF)First published: 08/02/2019 Last updated: 02/09/2025 View Other languages (25) български (BG) (93.36 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View español (ES) (81.97 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View čeština (CS) (93.99 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View dansk (DA) (83.34 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View Deutsch (DE) (82.76 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View eesti keel (ET) (82.18 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View ελληνικά (EL) (93.76 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View français (FR) (82.44 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View hrvatski (HR) (92.27 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View íslenska (IS) (83.29 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View Gaeilge (GA) (83.57 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View italiano (IT) (82.29 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View latviešu valoda (LV) (94.29 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View lietuvių kalba (LT) (94.03 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View magyar (HU) (94.15 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View Malti (MT) (95.95 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View Nederlands (NL) (82.05 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View norsk (NO) (82 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View polski (PL) (95.62 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View português (PT) (83.01 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View română (RO) (94.17 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View slovenčina (SK) (94.08 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View slovenščina (SL) (82.27 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View Suomi (FI) (81.54 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View svenska (SV) (82.05 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View Product details Name of medicine Syvazul BTV Active substance Inactivated bluetongue virus, serotype 1, strain ALG2006/01 E1Inactivated bluetongue virus, serotype 4, strain BTV-4/SPA-1/2004Inactivated bluetongue virus, serotype 8, strain BEL2006/01 International non-proprietary name (INN) or common name bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3) Pharmacotherapeutic groupImmunologicals for OvidaeImmunologicals for BovidaeInactivated viral vaccines Authorisation details EMA product number EMEA/V/C/004611 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Syvazul BTV : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (81.94 KB - PDF)First published: 19/09/2019 Last updated: 02/09/2025 View Initial marketing authorisation documents Syvazul BTV : EPAR - Public assessment reportAdopted Reference Number: EMA/802733/2018 English (EN) (81.49 KB - PDF)First published: 08/02/2019 Last updated: 02/09/2025 View CVMP summary of opinion for Syvazul BTVAdopted Reference Number: EMA/CVMP/735427/2018 English (EN) (75.94 KB - PDF)First published: 09/11/2018 View News on Syvazul BTV 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) 13-14 February 202416/02/2024 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) 14-16 February 202317/02/2023 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) 8-10 December 202011/12/2020 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 May 202025/05/2020 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 6-8 November 201809/11/2018 This page was last updated on 02/09/2025 Share this page