BTVPUR RSS Authorised This medicine is authorised for use in the European Union inactivated vaccine against bluetongue virus serotypes 1 and 8 Medicine Veterinary Authorised
Page contentsPage contents Overview Product information Product details Authorisation details Assessment history News on BTVPUR Topics 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 BTVPUR : EPAR - Medicine overview English (EN) (81.94 KB - PDF)First published: 03/01/2011 Last updated: 24/10/2024 View Other languages (25) български (BG) (93.36 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View español (ES) (81.97 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View čeština (CS) (93.99 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View dansk (DA) (83.34 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View Deutsch (DE) (82.76 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View eesti keel (ET) (82.18 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View ελληνικά (EL) (93.76 KB - 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PDF) First published: 03/01/2011 Last updated: 24/10/2024 View Deutsch (DE) (81.72 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View eesti keel (ET) (81.22 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View ελληνικά (EL) (91.79 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View français (FR) (81.63 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View hrvatski (HR) (91.56 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View íslenska (IS) (81.52 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View Gaeilge (GA) (81.36 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View italiano (IT) (81.76 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View latviešu valoda (LV) (92.14 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View lietuvių kalba (LT) (92.19 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View magyar (HU) (92.76 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View Malti (MT) (93.86 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View Nederlands (NL) (81.15 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View norsk (NO) (81.52 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View polski (PL) (93.22 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View português (PT) (82.53 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View română (RO) (91.73 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View slovenčina (SK) (81.75 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View slovenščina (SL) (81.76 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View Suomi (FI) (81.11 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View svenska (SV) (81.47 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View BTVPUR : EPAR - All Authorised presentations English (EN) (81.94 KB - PDF)First published: 03/01/2011 Last updated: 24/10/2024 View Other languages (25) български (BG) (93.36 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View español (ES) (81.97 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View čeština (CS) (93.99 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View dansk (DA) (83.34 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View Deutsch (DE) (82.76 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View eesti keel (ET) (82.18 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View ελληνικά (EL) (93.76 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View français (FR) (82.44 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View hrvatski (HR) (92.27 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View íslenska (IS) (83.29 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View Gaeilge (GA) (83.57 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View italiano (IT) (82.29 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View latviešu valoda (LV) (94.29 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View lietuvių kalba (LT) (94.03 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View magyar (HU) (94.15 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View Malti (MT) (95.95 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View Nederlands (NL) (82.05 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View norsk (NO) (82 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View polski (PL) (95.62 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View português (PT) (83.01 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View română (RO) (94.17 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View slovenčina (SK) (94.08 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View slovenščina (SL) (82.27 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View Suomi (FI) (81.54 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View svenska (SV) (82.05 KB - PDF) First published: 03/01/2011 Last updated: 24/10/2024 View Product details Name of medicine BTVPUR Active substance bluetongue-virus serotype-1 antigenbluetongue virus serotype 8 antigen International non-proprietary name (INN) or common name inactivated vaccine against bluetongue virus serotypes 1 and 8 Authorisation details EMA product number EMEA/V/C/002231 Assessment history Expand section Collapse section Changes since initial authorisation of medicine BTVPUR : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (81.94 KB - PDF)First published: 04/05/2012 Last updated: 24/10/2024 View BTVPUR-V-C-2231-II-0010 : EPAR - Assessment Report - VariationAdopted Reference Number: EMA/427355/2018 English (EN) (81.49 KB - PDF)First published: 18/10/2018 Last updated: 24/10/2024 View BTVPUR-V-C-2231-II-0007-G : EPAR - Assessment Report - VariationAdopted Reference Number: EMA/145479/2016 English (EN) (81.49 KB - PDF)First published: 22/06/2016 Last updated: 25/10/2024 View CVMP post-authorisation summary of positive opinion for BTVPUR AlSap 1-8Adopted Reference Number: EMEA/CVMP/66986/2016 English (EN) (60.64 KB - PDF)First published: 19/02/2016 Last updated: 19/02/2016 View BTVPUR AlSap 1-8-V-C-2231-S-0002 : EPAR - Annual re-assessment reportAdopted Reference Number: EMA/136808/2013 English (EN) (81.49 KB - PDF)First published: 13/05/2013 Last updated: 24/10/2024 View Initial marketing authorisation documents BTVPUR AlSap 1-8 : EPAR - Scientific DiscussionReference Number: EMA/CVMP/622534/2010 English (EN) (81.49 KB - PDF)First published: 03/01/2011 Last updated: 24/10/2024 View CVMP summary of positive opinion for BTVPUR AlSap 1-8Adopted Reference Number: EMA/CVMP/343726/2010 English (EN) (82.26 KB - PDF)First published: 15/10/2010 Last updated: 15/10/2010 View News on BTVPUR 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) 14-16 February 202317/02/2023 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 December 202209/12/2022 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 March 202218/03/2022 Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 15-17 June 202118/06/2021 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19–21 June 201822/06/2018 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 14-16 February 201717/02/2017 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 19-21 April 201622/04/2016 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 16-18 February 201619/02/2016 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 7-9 July 201510/07/2015 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 2-4 June 201505/06/2015 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 5-7 May 201508/05/2015 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 November 201407/11/2014 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 May 201412/05/2014 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 5-7 November 201308/11/2013 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 14-16 May 201317/05/2013 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5-7 February 201308/02/2013 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 14-16 May 201222/05/2012 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 7-9 February 201210/02/2012 Topics Medicines This page was last updated on 24/10/2024 Share this page