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)MedicineVeterinaryAuthorised
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 - 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 information Syvazul BTV : EPAR - Product information English (EN) (81.49 KB - PDF)First published: 08/02/2019 Last updated: 02/09/2025 View Other languages (25) български (BG) (91.78 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View español (ES) (81.51 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View čeština (CS) (92.48 KB - PDF) First published: 08/02/2019 Last updated: 02/09/2025 View dansk (DA) (82.05 KB - 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