BTVPUR Alsap 8
Withdrawn
This medicine's authorisation has been withdrawn
adjuvanted bluetongue virus vaccine
MedicineVeterinaryWithdrawn
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
The marketing authorisation for BTVPUR AlSap 8 has been withdrawn at the request of the marketing-authorisation holder.
BTVPUR Alsap 8 : EPAR - Summary for the public
Reference Number: EMA/116345/2009
English (EN) (216.22 KB - PDF)
First published: Last updated:
български (BG) (276.19 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
español (ES) (214.85 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
čeština (CS) (282.09 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
dansk (DA) (238.31 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
Deutsch (DE) (217.39 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
eesti keel (ET) (214.24 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
ελληνικά (EL) (304.53 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
français (FR) (239.03 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
italiano (IT) (215.73 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
latviešu valoda (LV) (94.58 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
lietuvių kalba (LT) (119.27 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
magyar (HU) (257.98 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
Malti (MT) (122.68 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
Nederlands (NL) (71.87 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
polski (PL) (100.02 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
português (PT) (71.88 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
română (RO) (118.17 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
slovenčina (SK) (120.6 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
slovenščina (SL) (110.34 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
Suomi (FI) (216.27 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
svenska (SV) (71.75 KB - PDF)
First published: 19/04/2013Last updated: 16/05/2018
Product information
BTVPUR Alsap 8 : EPAR - Product Information
English (EN) (409.23 KB - PDF)
First published: Last updated:
български (BG) (743.97 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
español (ES) (471.21 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
čeština (CS) (625.92 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
dansk (DA) (404.57 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
Deutsch (DE) (481.49 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
eesti keel (ET) (481.1 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
ελληνικά (EL) (760 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
français (FR) (417.92 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
hrvatski (HR) (521.62 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
íslenska (IS) (401.48 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
italiano (IT) (414.09 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
latviešu valoda (LV) (649.44 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
lietuvių kalba (LT) (540.05 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
magyar (HU) (652.27 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
Malti (MT) (653.21 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
Nederlands (NL) (474.89 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
norsk (NO) (402.13 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
polski (PL) (661.05 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
português (PT) (476.05 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
română (RO) (543.38 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
slovenčina (SK) (663.03 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
slovenščina (SL) (624.08 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
Suomi (FI) (407.04 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
svenska (SV) (406.34 KB - PDF)
First published: 26/01/2010Last updated: 17/05/2018
Latest procedure affecting product information:
R/0010
13/03/2014
BTVPUR Alsap 8 : EPAR - All Authorised presentations
English (EN) (168.89 KB - PDF)
First published: Last updated:
български (BG) (241.84 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
español (ES) (177.73 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
čeština (CS) (211.31 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
dansk (DA) (164.97 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
Deutsch (DE) (173.27 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
eesti keel (ET) (172.66 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
ελληνικά (EL) (237.8 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
français (FR) (165.01 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
íslenska (IS) (166.62 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
italiano (IT) (166.47 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
latviešu valoda (LV) (214.89 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
lietuvių kalba (LT) (212.85 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
magyar (HU) (204.67 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
Malti (MT) (225.73 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
Nederlands (NL) (172.82 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
norsk (NO) (164.38 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
polski (PL) (236.78 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
português (PT) (176.81 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
română (RO) (210.41 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
slovenčina (SK) (210.94 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
slovenščina (SL) (209.82 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
Suomi (FI) (173.21 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
svenska (SV) (165.48 KB - PDF)
First published: 10/03/2009Last updated: 17/05/2018
Product details
- Name of medicine
- BTVPUR Alsap 8
- Active substance
- bluetongue virus serotype 8 antigen
- International non-proprietary name (INN) or common name
- adjuvanted bluetongue virus vaccine
- Species
- Sheep
- Cattle
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI02AA08
Pharmacotherapeutic group
- Immunologicals for Ovidae
- Immunologicals for Bovidae
Therapeutic indication
Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.
*(below the level of detection by the validated RT-PCR method at 3.14log10 RNA copies/ml, indicating no infectious virus transmission).
Onset of immunity has been demonstrated 3 weeks after the primary vaccination course.
The duration of immunity for cattle and sheep is 1 year after the primary vaccination course.
The duration of immunity is not yet fully established in cattle or sheep, although interim results of ongoing studies demonstrate that the duration is at least 6 months after the primary vaccination course in sheep.
Authorisation details
- EMA product number
- EMEA/V/C/000146
- Marketing authorisation holder
- Merial
29 Avenue Tony Garnier
69007 Lyon
France - Marketing authorisation issued
- 17/03/2009
- Revision
- 5
Assessment history
BTVPUR Alsap 8 : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (213.44 KB - PDF)
First published: Last updated:
BTVPUR Alsap 8-V-C-146-S-08 : EPAR - Assessment Report - Variation
AdoptedReference Number: EMA/471401/2012
English (EN) (308.64 KB - PDF)
First published: Last updated:
BTVPUR Alsap 8 : EPAR - Scientific Discussion
English (EN) (619.07 KB - PDF)
First published: Last updated:
BTVPUR Alsap 8 : EPAR - Procedural steps taken before authorisation
English (EN) (193.91 KB - PDF)
First published: Last updated:
Committee for medicinal products for veterinary use summary of opinion: BTVPUR Alsap 8: International Non-proprietary Names (INN): inactivated bluetongue virus Serotype 8
AdoptedReference Number: EMEA/CVMP/685571/2008
English (EN) (168.92 KB - PDF)
First published: Last updated:
News on BTVPUR Alsap 8
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