Zulvac 1 Bovis

RSS
Withdrawn

This medicine's authorisation has been withdrawn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The marketing authorisation for Zulvac 1 Bovis has been withdrawn at the request of the marketing authorisation holder.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)

First published: Last updated:
View

български (BG) (509.58 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

español (ES) (384.95 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

čeština (CS) (451.17 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

dansk (DA) (381.07 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

Deutsch (DE) (409.83 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

eesti keel (ET) (379.73 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

ελληνικά (EL) (514.35 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

français (FR) (409.54 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

italiano (IT) (408.74 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

latviešu valoda (LV) (471.49 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

lietuvių kalba (LT) (435.02 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

magyar (HU) (456.96 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

Malti (MT) (438.24 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

Nederlands (NL) (385.42 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

polski (PL) (464.22 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

português (PT) (408.96 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

română (RO) (415.31 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

slovenčina (SK) (436.84 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

slovenščina (SL) (455.38 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

Suomi (FI) (403.39 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

svenska (SV) (384.08 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

Product information

Zulvac 1 Bovis : EPAR - Product information

English (EN) (369.04 KB - PDF)

First published: Last updated:
View

български (BG) (735.77 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

español (ES) (588.23 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

čeština (CS) (780.58 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

dansk (DA) (591.89 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

Deutsch (DE) (573.04 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

eesti keel (ET) (586.69 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

ελληνικά (EL) (905.3 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

français (FR) (614.9 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

hrvatski (HR) (652.84 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

íslenska (IS) (595.81 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

italiano (IT) (604.98 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

latviešu valoda (LV) (807.34 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

lietuvių kalba (LT) (651.56 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

magyar (HU) (796.39 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

Malti (MT) (798.16 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

Nederlands (NL) (607.21 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

norsk (NO) (604.74 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

polski (PL) (780.98 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

português (PT) (603.86 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

română (RO) (667.48 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

slovenčina (SK) (811.09 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

slovenščina (SL) (776.57 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

Suomi (FI) (586.27 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

svenska (SV) (591.79 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View
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:
View

български (BG) (230.28 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

español (ES) (343.83 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

čeština (CS) (369.47 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

dansk (DA) (347.52 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

Deutsch (DE) (348.53 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

eesti keel (ET) (355.15 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

ελληνικά (EL) (383.16 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

français (FR) (344.14 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

hrvatski (HR) (356.23 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

íslenska (IS) (322.68 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

italiano (IT) (357.42 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

latviešu valoda (LV) (383.76 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

lietuvių kalba (LT) (373.86 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

magyar (HU) (368 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

Malti (MT) (387.39 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

Nederlands (NL) (347.91 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

norsk (NO) (343.71 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

polski (PL) (386.15 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

português (PT) (356.42 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

română (RO) (360.37 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

slovenčina (SK) (371.83 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

slovenščina (SL) (382.39 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

Suomi (FI) (346.35 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

svenska (SV) (359.59 KB - PDF)

First published: 10/10/2011 Last updated: 30/03/2020
View

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

English (EN) (283.76 KB - PDF)

First published: Last updated:
View

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

Adopted Reference Number: EMA/119947/2013

English (EN) (481.82 KB - PDF)

First published: Last updated:
View

Zulvac 1 Bovis : EPAR - Scientific discussion

Reference Number: EMA/457917/2011

English (EN) (380.27 KB - PDF)

First published: Last updated:
View

CVMP summary of positive opinion for Zulvac 1 Bovis

Adopted Reference Number: EMA/CVMP/506555/2010

English (EN) (278.29 KB - PDF)

First published: Last updated:
View
This page was last updated on

Share this page