Zulvac 8 Bovis
Withdrawn
This medicine's authorisation has been withdrawn
inactivated 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The marketing authorisation for this product has been withdrawn at the request of the marketing authorisation holder.
Zulvac 8 Bovis : EPAR - Summary for the public
Reference Number: EMA/CVMP/643080/2009
English (EN) (262.42 KB - PDF)
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български (BG) (394.36 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
español (ES) (273.62 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
čeština (CS) (732.68 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
dansk (DA) (455.05 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
Deutsch (DE) (279.59 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
eesti keel (ET) (286.49 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
ελληνικά (EL) (364.56 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
français (FR) (302.11 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
italiano (IT) (274.63 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
latviešu valoda (LV) (327.75 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
lietuvių kalba (LT) (319.37 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
magyar (HU) (319.09 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
Malti (MT) (349.32 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
Nederlands (NL) (277.61 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
polski (PL) (557.29 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
português (PT) (297.96 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
română (RO) (502.78 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
slovenčina (SK) (321.18 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
slovenščina (SL) (327.97 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
Suomi (FI) (296.79 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
svenska (SV) (274.99 KB - PDF)
First published: 19/04/2013Last updated: 06/05/2014
Product information
Zulvac 8 Bovis : EPAR - Product Information
English (EN) (535.76 KB - PDF)
First published: Last updated:
български (BG) (854.08 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
español (ES) (446.08 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
čeština (CS) (960.58 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
dansk (DA) (942.41 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
Deutsch (DE) (454 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
eesti keel (ET) (445.99 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
ελληνικά (EL) (796.2 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
français (FR) (469.55 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
hrvatski (HR) (474.59 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
íslenska (IS) (521.51 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
italiano (IT) (449.11 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
latviešu valoda (LV) (645.13 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
lietuvių kalba (LT) (450.71 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
magyar (HU) (640.36 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
Malti (MT) (642.9 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
Nederlands (NL) (448.33 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
norsk (NO) (777.6 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
polski (PL) (1.01 MB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
português (PT) (465.13 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
română (RO) (759.05 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
slovenčina (SK) (601.1 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
slovenščina (SL) (619.58 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
Suomi (FI) (448.79 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
svenska (SV) (437.53 KB - PDF)
First published: 21/01/2010Last updated: 11/04/2017
Latest procedure affecting product information:
IG/0747
23/03/2017
Zulvac 8 Bovis : EPAR - All Authorised presentations
English (EN) (537.75 KB - PDF)
First published: Last updated:
български (BG) (624.22 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
español (ES) (222.31 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
čeština (CS) (433.35 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
dansk (DA) (226.08 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
Deutsch (DE) (183.4 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
eesti keel (ET) (220.22 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
ελληνικά (EL) (432.41 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
français (FR) (221.57 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
italiano (IT) (219.75 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
latviešu valoda (LV) (273.68 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
lietuvių kalba (LT) (420.63 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
magyar (HU) (379.71 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
Malti (MT) (277.41 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
Nederlands (NL) (226.13 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
polski (PL) (271.54 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
português (PT) (380.5 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
română (RO) (255.01 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
slovenčina (SK) (270.57 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
slovenščina (SL) (267.88 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
Suomi (FI) (219.04 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
svenska (SV) (387.87 KB - PDF)
First published: 21/01/2010Last updated: 21/01/2010
Product details
- Name of medicine
- Zulvac 8 Bovis
- Active substance
- inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02
- International non-proprietary name (INN) or common name
- inactivated bluetongue virus, serotype 8
- Species
- Cattle
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI02AA08
Pharmacotherapeutic group
ImmunologicalsTherapeutic indication
Active immunisation of cattle from three months of age for the prevention of viraemia caused by bluetongue virus, serotype 8.
Authorisation details
- EMA product number
- EMEA/V/C/000145
- Marketing authorisation holder
- Zoetis Belgium
Zoetis Belgium
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium - Marketing authorisation issued
- 15/01/2010
- Revision
- 7
Assessment history
Zulvac 8 Bovis : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (436.56 KB - PDF)
First published: Last updated:
Zulvac 8 Bovis-V-C-145-S-09 : EPAR - Assessment Report - Variation
AdoptedReference Number: EMA/276757/2013
English (EN) (827.19 KB - PDF)
First published: Last updated:
Zulvac 8 Bovis V-C-145-II-02 : EPAR - Scientific Discussion - Variation
AdoptedReference Number: EMA/249800/2011
English (EN) (268.93 KB - PDF)
First published: Last updated:
Zulvac 8 Bovis : EPAR - Procedural steps taken before authorisation
English (EN) (200.36 KB - PDF)
First published: Last updated:
Zulvac 8 Bovis : EPAR - Scientific Discussion
English (EN) (389.32 KB - PDF)
First published: Last updated:
Committee for medicinal products for veterinary use summary of opinion: Zulvac 8 Bovis: International Non-proprietary Names (INN): inactivated Bluetongue Virus (BTV) Serotype 8
AdoptedReference Number: EMEA/CVMP/665815/2008
English (EN) (236.81 KB - PDF)
First published: Last updated:
News on Zulvac 8 Bovis
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