Zulvac 1 Bovis
Withdrawn
This medicine's authorisation has been withdrawn
inactivated bluetongue virus, serotype 1
MedicineVeterinaryWithdrawn
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
The marketing authorisation for Zulvac 1 Bovis has been withdrawn at the request of the marketing authorisation holder.
Zulvac 1 Bovis : EPAR - Summary for the public
Reference Number: EMA/457915/2011
English (EN) (222.99 KB - PDF)
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български (BG) (509.58 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
español (ES) (384.95 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
čeština (CS) (451.17 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
dansk (DA) (381.07 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
Deutsch (DE) (409.83 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
eesti keel (ET) (379.73 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
ελληνικά (EL) (514.35 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
français (FR) (409.54 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
italiano (IT) (408.74 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
latviešu valoda (LV) (471.49 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
lietuvių kalba (LT) (435.02 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
magyar (HU) (456.96 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
Malti (MT) (438.24 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
Nederlands (NL) (385.42 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
polski (PL) (464.22 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
português (PT) (408.96 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
română (RO) (415.31 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
slovenčina (SK) (436.84 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
slovenščina (SL) (455.38 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
Suomi (FI) (403.39 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
svenska (SV) (384.08 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
Product information
Zulvac 1 Bovis : EPAR - Product information
English (EN) (369.04 KB - PDF)
First published: Last updated:
български (BG) (735.77 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
español (ES) (588.23 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
čeština (CS) (780.58 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
dansk (DA) (591.89 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
Deutsch (DE) (573.04 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
eesti keel (ET) (586.69 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
ελληνικά (EL) (905.3 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
français (FR) (614.9 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
hrvatski (HR) (652.84 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
íslenska (IS) (595.81 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
italiano (IT) (604.98 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
latviešu valoda (LV) (807.34 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
lietuvių kalba (LT) (651.56 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
magyar (HU) (796.39 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
Malti (MT) (798.16 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
Nederlands (NL) (607.21 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
norsk (NO) (604.74 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
polski (PL) (780.98 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
português (PT) (603.86 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
română (RO) (667.48 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
slovenčina (SK) (811.09 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
slovenščina (SL) (776.57 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
Suomi (FI) (586.27 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
svenska (SV) (591.79 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
Latest procedure affecting product information:
IB/00017
21/06/2019
Zulvac 1 Bovis : EPAR - All authorised presentations
English (EN) (188.13 KB - PDF)
First published: Last updated:
български (BG) (230.28 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
español (ES) (343.83 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
čeština (CS) (369.47 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
dansk (DA) (347.52 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
Deutsch (DE) (348.53 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
eesti keel (ET) (355.15 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
ελληνικά (EL) (383.16 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
français (FR) (344.14 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
hrvatski (HR) (356.23 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
íslenska (IS) (322.68 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
italiano (IT) (357.42 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
latviešu valoda (LV) (383.76 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
lietuvių kalba (LT) (373.86 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
magyar (HU) (368 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
Malti (MT) (387.39 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
Nederlands (NL) (347.91 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
norsk (NO) (343.71 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
polski (PL) (386.15 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
português (PT) (356.42 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
română (RO) (360.37 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
slovenčina (SK) (371.83 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
slovenščina (SL) (382.39 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
Suomi (FI) (346.35 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
svenska (SV) (359.59 KB - PDF)
First published: 10/10/2011Last updated: 30/03/2020
Product details
- Name of medicine
- Zulvac 1 Bovis
- Active substance
- inactivated bluetongue virus, serotype 1
- International non-proprietary name (INN) or common name
- inactivated bluetongue virus, serotype 1
- Species
- Cattle
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI02AA08
Pharmacotherapeutic group
ImmunologicalsTherapeutic indication
Active immunisation of cattle from 2½ months of age for the prevention of viraemia caused by bluetongue virus, serotype 1.
Onset of immunity: 15 days after completion of the primary vaccination course.
Duration of immunity: 12 months.
Authorisation details
- EMA product number
- EMEA/V/C/002334
Accelerated assessment
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.
- Marketing authorisation holder
- Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium - Marketing authorisation issued
- 05/08/2011
- Revision
- 7
Assessment history
Zulvac 1 Bovis : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (283.76 KB - PDF)
First published: Last updated:
Zulvac 1 Bovis-V-C-2334-S-02 : EPAR - Assessment Report - Annual re-assessment
AdoptedReference Number: EMA/119947/2013
English (EN) (481.82 KB - PDF)
First published: Last updated:
Zulvac 1 Bovis : EPAR - Scientific discussion
Reference Number: EMA/457917/2011
English (EN) (380.27 KB - PDF)
First published: Last updated:
CVMP summary of positive opinion for Zulvac 1 Bovis
AdoptedReference Number: EMA/CVMP/506555/2010
English (EN) (278.29 KB - PDF)
First published: Last updated:
News on Zulvac 1 Bovis
This page was last updated on