- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
The marketing authorisation for this product has been withdrawn due to the application of the sunset clause.
BTVPUR AlSap 2-4 : EPAR - Summary for the public
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slovenščina (SL) (617.54 KB - PDF)
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Product information
BTVPUR AlSap 2-4 : EPAR - Product Information
English (EN) (690.26 KB - PDF)
български (BG) (1.22 MB - PDF)
español (ES) (687.65 KB - PDF)
čeština (CS) (1.04 MB - PDF)
dansk (DA) (688.86 KB - PDF)
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eesti keel (ET) (772.19 KB - PDF)
ελληνικά (EL) (1.25 MB - PDF)
français (FR) (689.37 KB - PDF)
hrvatski (HR) (800.01 KB - PDF)
íslenska (IS) (693.77 KB - PDF)
italiano (IT) (707.96 KB - PDF)
latviešu valoda (LV) (1.12 MB - PDF)
lietuvių kalba (LT) (1.12 MB - PDF)
magyar (HU) (1.07 MB - PDF)
Malti (MT) (1.09 MB - PDF)
Nederlands (NL) (687.27 KB - PDF)
norsk (NO) (697.66 KB - PDF)
polski (PL) (1.08 MB - PDF)
português (PT) (693.23 KB - PDF)
română (RO) (871.71 KB - PDF)
slovenčina (SK) (1.08 MB - PDF)
slovenščina (SL) (1.06 MB - PDF)
Suomi (FI) (694.6 KB - PDF)
svenska (SV) (684.36 KB - PDF)
BTVPUR AlSap 2-4 : EPAR - All Authorised presentations
English (EN) (494.2 KB - PDF)
български (BG) (562.4 KB - PDF)
español (ES) (492.41 KB - PDF)
čeština (CS) (554.66 KB - PDF)
dansk (DA) (491.23 KB - PDF)
Deutsch (DE) (492.86 KB - PDF)
eesti keel (ET) (491.18 KB - PDF)
ελληνικά (EL) (561.31 KB - PDF)
français (FR) (494.84 KB - PDF)
íslenska (IS) (493.06 KB - PDF)
italiano (IT) (492.12 KB - PDF)
latviešu valoda (LV) (556.38 KB - PDF)
lietuvių kalba (LT) (552.11 KB - PDF)
magyar (HU) (542.16 KB - PDF)
Malti (MT) (555.56 KB - PDF)
Nederlands (NL) (491.67 KB - PDF)
polski (PL) (563.97 KB - PDF)
português (PT) (493.05 KB - PDF)
română (RO) (537.37 KB - PDF)
slovenčina (SK) (543.7 KB - PDF)
slovenščina (SL) (535.77 KB - PDF)
Suomi (FI) (493.56 KB - PDF)
svenska (SV) (491.21 KB - PDF)
Product details
- Name of medicine
- BTVPUR AlSap 2-4
- Active substance
- bluetongue-virus serotype-2 antigen
- bluetongue-virus serotype-4 antigen
- International non-proprietary name (INN) or common name
- inactivated adjuvanted vaccine against bluetongue virus serotype 2 and 4 infections
- Species
- Sheep
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI04AA02
Pharmacotherapeutic group
- bluetongue virus
- Inactivated viral vaccines
- Immunologicals for Ovidae
Therapeutic indication
Active immunisation of sheep to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 2 and 4.
Authorisation details
- EMA product number
- EMEA/V/C/000139
- Marketing authorisation holder
- Mérial
29 avenue Tony Garnier
69007 Lyon
France - Marketing authorisation issued
- 04/11/2010
- Revision
- 4
Assessment history
BTVPUR AlSap 2-4 : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (538.14 KB - PDF)
BTVPUR AlSap 2-4-V-C-139-S-0004 : EPAR - Assessment Report - Annual re-assessment
English (EN) (749.25 KB - PDF)
BTVPUR AlSap 2-4 : EPAR - Scientific Discussion
English (EN) (1007.8 KB - PDF)
BTVPUR AlSap 2-4 : EPAR - Procedural steps taken before authorisation
English (EN) (581.84 KB - PDF)
CVMP summary of positive opinion for BTVPUR AlSap 2-4
English (EN) (555.41 KB - PDF)