BTVPUR AlSap 1
Withdrawn
This medicine's authorisation has been withdrawn
bluetongue-virus serotype-1 antigen
MedicineVeterinaryWithdrawn
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
The marketing authorisation for BTVPUR AlSap 1 has been withdrawn at the request of the marketing-authorisation holder.
BTVPUR AlSap 1 : EPAR - Summary for the public
Reference Number: EMA/CVMP/622300/2010
English (EN) (216.82 KB - PDF)
First published: Last updated:
български (BG) (273.86 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
español (ES) (219.81 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
čeština (CS) (279.88 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
dansk (DA) (215.41 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
Deutsch (DE) (241.24 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
eesti keel (ET) (244.85 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
ελληνικά (EL) (281.98 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
français (FR) (242.72 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
italiano (IT) (215.09 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
latviešu valoda (LV) (257.92 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
lietuvių kalba (LT) (242.99 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
magyar (HU) (257.59 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
Malti (MT) (287.39 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
Nederlands (NL) (215.61 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
polski (PL) (262.68 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
português (PT) (215.81 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
română (RO) (264.84 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
slovenčina (SK) (263.85 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
slovenščina (SL) (271.89 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
Suomi (FI) (214.4 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
svenska (SV) (215.45 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
Product information
BTVPUR AlSap 1 : EPAR - Product Information
Reference Number: EMA/CVMP/622300/2010
English (EN) (905.71 KB - PDF)
First published: Last updated:
български (BG) (1.59 MB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
español (ES) (959.08 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
čeština (CS) (1.31 MB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
dansk (DA) (976.46 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
Deutsch (DE) (1.05 MB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
eesti keel (ET) (962.08 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
ελληνικά (EL) (1.63 MB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
français (FR) (969.67 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
hrvatski (HR) (995.44 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
íslenska (IS) (1.21 MB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
italiano (IT) (409.73 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
latviešu valoda (LV) (588.19 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
lietuvių kalba (LT) (480.92 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
magyar (HU) (1.31 MB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
Malti (MT) (596.85 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
Nederlands (NL) (355.82 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
norsk (NO) (410.45 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
polski (PL) (595.12 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
português (PT) (421.48 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
română (RO) (479.93 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
slovenčina (SK) (582.8 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
slovenščina (SL) (563.67 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
Suomi (FI) (942.5 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
svenska (SV) (419.01 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
Latest procedure affecting product information:
R/0005
08/09/2015
BTVPUR AlSap 1 : EPAR - All Authorised presentations
Reference Number: EMA/CVMP/622300/2010
English (EN) (165.08 KB - PDF)
First published: Last updated:
български (BG) (237.24 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
español (ES) (179.61 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
čeština (CS) (214.8 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
dansk (DA) (168.71 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
Deutsch (DE) (181.32 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
eesti keel (ET) (216.18 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
ελληνικά (EL) (224.9 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
français (FR) (168.45 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
hrvatski (HR) (203.36 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
íslenska (IS) (171.81 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
italiano (IT) (166.05 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
latviešu valoda (LV) (222.44 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
lietuvių kalba (LT) (215.2 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
magyar (HU) (208.44 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
Malti (MT) (226.37 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
Nederlands (NL) (169.29 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
norsk (NO) (166.89 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
polski (PL) (215.44 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
português (PT) (180.94 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
română (RO) (212.26 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
slovenčina (SK) (211.23 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
slovenščina (SL) (210.68 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
Suomi (FI) (168.59 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
svenska (SV) (168.12 KB - PDF)
First published: 03/01/2011Last updated: 17/05/2018
Product details
- Name of medicine
- BTVPUR AlSap 1
- Active substance
- bluetongue-virus serotype-1 antigen
- International non-proprietary name (INN) or common name
- bluetongue-virus serotype-1 antigen
- Species
- Sheep
- Cattle
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI04AA02
Pharmacotherapeutic group
ImmunologicalsTherapeutic indication
Active immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotype 1.
Onset of immunity has been demonstrated three weeks after the primary vaccination course. The duration of immunity for cattle and sheep is one year after the primary vaccination course.
Authorisation details
- EMA product number
- EMEA/V/C/002230
- Marketing authorisation holder
- Merial
29 Avenue Tony Garnier
69007 Lyon
France - Marketing authorisation issued
- 17/12/2010
- Revision
- 4
Assessment history
BTVPUR AlSap 1 : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (202.88 KB - PDF)
First published: Last updated:
BTVPUR AlSap 1-V-C-2230-S-02 : EPAR - Assessment Report - Annual re-assessment
AdoptedReference Number: EMA/136739/2013
English (EN) (406.33 KB - PDF)
First published: Last updated:
BTVPUR AlSap 1 : EPAR - Scientific Discussion
Reference Number: EMA/CVMP/622300/2010
English (EN) (509.9 KB - PDF)
First published: Last updated:
CVMP summary of positive opinion for BTVPUR AlSap 1
AdoptedReference Number: EMA/CVMP/343642/2010
English (EN) (224.61 KB - PDF)
First published: Last updated:
News on BTVPUR AlSap 1
This page was last updated on