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The marketing authorisation for Zulvac 1 Bovis has been withdrawn at the request of the marketing authorisation holder.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

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Product information

Zulvac 1 Bovis : EPAR - Product information

български (BG) (735.77 KB - PDF)
español (ES) (588.23 KB - PDF)
čeština (CS) (780.58 KB - PDF)
dansk (DA) (591.89 KB - PDF)
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eesti keel (ET) (586.69 KB - PDF)
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français (FR) (614.9 KB - PDF)
hrvatski (HR) (652.84 KB - PDF)
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italiano (IT) (604.98 KB - PDF)
latviešu valoda (LV) (807.34 KB - PDF)
lietuvių kalba (LT) (651.56 KB - PDF)
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polski (PL) (780.98 KB - PDF)
português (PT) (603.86 KB - PDF)
română (RO) (667.48 KB - PDF)
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slovenščina (SL) (776.57 KB - PDF)
Suomi (FI) (586.27 KB - PDF)
svenska (SV) (591.79 KB - PDF)

Latest procedure affecting product information: IB/00017

21/06/2019

Zulvac 1 Bovis : EPAR - All authorised presentations

български (BG) (230.28 KB - PDF)
español (ES) (343.83 KB - PDF)
čeština (CS) (369.47 KB - PDF)
dansk (DA) (347.52 KB - PDF)
Deutsch (DE) (348.53 KB - PDF)
eesti keel (ET) (355.15 KB - PDF)
ελληνικά (EL) (383.16 KB - PDF)
français (FR) (344.14 KB - PDF)
hrvatski (HR) (356.23 KB - PDF)
íslenska (IS) (322.68 KB - PDF)
italiano (IT) (357.42 KB - PDF)
latviešu valoda (LV) (383.76 KB - PDF)
lietuvių kalba (LT) (373.86 KB - PDF)
magyar (HU) (368 KB - PDF)
Malti (MT) (387.39 KB - PDF)
Nederlands (NL) (347.91 KB - PDF)
norsk (NO) (343.71 KB - PDF)
polski (PL) (386.15 KB - PDF)
português (PT) (356.42 KB - PDF)
română (RO) (360.37 KB - PDF)
slovenčina (SK) (371.83 KB - PDF)
slovenščina (SL) (382.39 KB - PDF)
Suomi (FI) (346.35 KB - PDF)
svenska (SV) (359.59 KB - PDF)

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

Immunologicals

Therapeutic 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

Zulvac 1 Bovis-V-C-2334-S-02 : EPAR - Assessment Report - Annual re-assessment

Zulvac 1 Bovis : EPAR - Scientific discussion

CVMP summary of positive opinion for Zulvac 1 Bovis

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