Bovilis BTV8

RSS
Withdrawn

This medicine's authorisation has been withdrawn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The marketing authorisation for this product has been withdrawn at the request of the marketing authorisation holder.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)

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български (BG) (1.31 MB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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español (ES) (636.36 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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čeština (CS) (706.5 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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dansk (DA) (659.36 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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Deutsch (DE) (636.58 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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eesti keel (ET) (635.16 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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ελληνικά (EL) (752.17 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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français (FR) (636.97 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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hrvatski (HR) (656.66 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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italiano (IT) (635.19 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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latviešu valoda (LV) (688.95 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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lietuvių kalba (LT) (659.14 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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magyar (HU) (702.54 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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Malti (MT) (732.54 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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Nederlands (NL) (635.98 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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polski (PL) (729.46 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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português (PT) (635.86 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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română (RO) (681.7 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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slovenčina (SK) (709.46 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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slovenščina (SL) (719.53 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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Suomi (FI) (635.19 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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svenska (SV) (635.66 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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Product information

Bovilis BTV8 : EPAR - Product Information

English (EN) (930.24 KB - PDF)

First published: Last updated:
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български (BG) (1.51 MB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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español (ES) (901.04 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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čeština (CS) (1.24 MB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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dansk (DA) (913.53 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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Deutsch (DE) (893.34 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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eesti keel (ET) (922.51 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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ελληνικά (EL) (1.4 MB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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français (FR) (901.25 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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hrvatski (HR) (958.78 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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íslenska (IS) (914.86 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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italiano (IT) (939.75 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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latviešu valoda (LV) (1.27 MB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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lietuvių kalba (LT) (992 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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magyar (HU) (1.29 MB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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Malti (MT) (1.28 MB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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Nederlands (NL) (967.17 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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norsk (NO) (934.46 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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polski (PL) (1.29 MB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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português (PT) (924.18 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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română (RO) (994.45 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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slovenčina (SK) (1.28 MB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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slovenščina (SL) (1.27 MB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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Suomi (FI) (908.56 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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svenska (SV) (911.53 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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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:
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български (BG) (1.38 MB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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español (ES) (628.23 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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čeština (CS) (788.09 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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dansk (DA) (657.18 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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Deutsch (DE) (617.45 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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eesti keel (ET) (653.76 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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ελληνικά (EL) (838.45 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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français (FR) (650.09 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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italiano (IT) (654.14 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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latviešu valoda (LV) (801.03 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
View

lietuvių kalba (LT) (695.55 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
View

magyar (HU) (782.34 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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Malti (MT) (791.5 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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Nederlands (NL) (657.77 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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polski (PL) (792.51 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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português (PT) (658.03 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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română (RO) (686.98 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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slovenčina (SK) (791.96 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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slovenščina (SL) (782.58 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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Suomi (FI) (655.63 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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svenska (SV) (650.31 KB - PDF)

First published: 09/09/2010 Last updated: 27/07/2022
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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)

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Bovilis BTV8 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/298161/2014

English (EN) (767.57 KB - PDF)

First published: Last updated:
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Bovilis BTV8 : EPAR - Scientific Discussion

Reference Number: EMA/CVMP/234334/2009

English (EN) (887.44 KB - PDF)

First published: Last updated:
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Bovilis BTV8 : EPAR - Procedural steps taken before authorisation

Reference Number: EMA/CVMP/234339/2009

English (EN) (650.67 KB - PDF)

First published: Last updated:
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CVMP summary of positive opinion for Bovilis BTV8

Adopted Reference Number: EMA/CVMP/115976/2009

English (EN) (631.11 KB - PDF)

First published: Last updated:
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