Bovilis BTV8
Withdrawn
This medicine's authorisation has been withdrawn
bluetongue virus serotype 8
MedicineVeterinaryWithdrawn
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
The marketing authorisation for this product has been withdrawn at the request of the marketing authorisation holder.
Bovilis BTV8 : EPAR - Summary for the public
Reference Number: EMA/CVMP/234332/2009
English (EN) (637.25 KB - PDF)
First published: Last updated:
български (BG) (1.31 MB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
español (ES) (636.36 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
čeština (CS) (706.5 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
dansk (DA) (659.36 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
Deutsch (DE) (636.58 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
eesti keel (ET) (635.16 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
ελληνικά (EL) (752.17 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
français (FR) (636.97 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
hrvatski (HR) (656.66 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
italiano (IT) (635.19 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
latviešu valoda (LV) (688.95 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
lietuvių kalba (LT) (659.14 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
magyar (HU) (702.54 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
Malti (MT) (732.54 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
Nederlands (NL) (635.98 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
polski (PL) (729.46 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
português (PT) (635.86 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
română (RO) (681.7 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
slovenčina (SK) (709.46 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
slovenščina (SL) (719.53 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
Suomi (FI) (635.19 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
svenska (SV) (635.66 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
Product information
Bovilis BTV8 : EPAR - Product Information
English (EN) (930.24 KB - PDF)
First published: Last updated:
български (BG) (1.51 MB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
español (ES) (901.04 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
čeština (CS) (1.24 MB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
dansk (DA) (913.53 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
Deutsch (DE) (893.34 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
eesti keel (ET) (922.51 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
ελληνικά (EL) (1.4 MB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
français (FR) (901.25 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
hrvatski (HR) (958.78 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
íslenska (IS) (914.86 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
italiano (IT) (939.75 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
latviešu valoda (LV) (1.27 MB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
lietuvių kalba (LT) (992 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
magyar (HU) (1.29 MB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
Malti (MT) (1.28 MB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
Nederlands (NL) (967.17 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
norsk (NO) (934.46 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
polski (PL) (1.29 MB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
português (PT) (924.18 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
română (RO) (994.45 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
slovenčina (SK) (1.28 MB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
slovenščina (SL) (1.27 MB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
Suomi (FI) (908.56 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
svenska (SV) (911.53 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
Latest procedure affecting product information:
R/0007
05/06/2015
Bovilis BTV8 : EPAR - All Authorised presentations
English (EN) (624.18 KB - PDF)
First published: Last updated:
български (BG) (1.38 MB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
español (ES) (628.23 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
čeština (CS) (788.09 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
dansk (DA) (657.18 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
Deutsch (DE) (617.45 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
eesti keel (ET) (653.76 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
ελληνικά (EL) (838.45 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
français (FR) (650.09 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
italiano (IT) (654.14 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
latviešu valoda (LV) (801.03 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
lietuvių kalba (LT) (695.55 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
magyar (HU) (782.34 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
Malti (MT) (791.5 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
Nederlands (NL) (657.77 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
polski (PL) (792.51 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
português (PT) (658.03 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
română (RO) (686.98 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
slovenčina (SK) (791.96 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
slovenščina (SL) (782.58 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
Suomi (FI) (655.63 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
svenska (SV) (650.31 KB - PDF)
First published: 09/09/2010Last updated: 27/07/2022
Product details
- Name of medicine
- Bovilis BTV8
- Active substance
- bluetongue virus vaccine, serotype 8 (inactivated)
- International non-proprietary name (INN) or common name
- bluetongue virus serotype 8
- Species
- Sheep
- Cattle
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI04AA02
Pharmacotherapeutic group
- Inactivated viral vaccines
- bluetongue virus
- SHEEP
Therapeutic indication
Cattle
To stimulate active immunity in sheep from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia
Sheep
To stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia
Authorisation details
- EMA product number
- EMEA/V/C/000148
- Marketing authorisation holder
- Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands - Marketing authorisation issued
- 06/09/2010
- Revision
- 4
Assessment history
Bovilis BTV8 : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (619.59 KB - PDF)
First published: Last updated:
Bovilis BTV8 : EPAR - Assessment Report - Variation
AdoptedReference Number: EMA/298161/2014
English (EN) (767.57 KB - PDF)
First published: Last updated:
Bovilis BTV8 : EPAR - Scientific Discussion
Reference Number: EMA/CVMP/234334/2009
English (EN) (887.44 KB - PDF)
First published: Last updated:
Bovilis BTV8 : EPAR - Procedural steps taken before authorisation
Reference Number: EMA/CVMP/234339/2009
English (EN) (650.67 KB - PDF)
First published: Last updated:
CVMP summary of positive opinion for Bovilis BTV8
AdoptedReference Number: EMA/CVMP/115976/2009
English (EN) (631.11 KB - PDF)
First published: Last updated:
News on Bovilis BTV8
This page was last updated on