Zulvac 1 Ovis
Withdrawn
This medicine's authorisation has been withdrawn
inactivated bluetongue virus, serotype-1
MedicineVeterinaryWithdrawn
Overview
The marketing authorisation for Zulvac 1 Ovis has been withdrawn at the request of the marketing-authorisation holder.
Zulvac 1 Ovis : EPAR - Summary for the public
English (EN) (341.26 KB - PDF)
First published: Last updated:
български (BG) (387.71 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
español (ES) (324.29 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
čeština (CS) (367.61 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
dansk (DA) (311.6 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
Deutsch (DE) (339.3 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
ελληνικά (EL) (425.96 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
français (FR) (340.13 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
italiano (IT) (335.8 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
latviešu valoda (LV) (411.71 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
lietuvių kalba (LT) (350.56 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
magyar (HU) (383.87 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
Malti (MT) (373.83 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
Nederlands (NL) (320.6 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
polski (PL) (381.01 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
português (PT) (329.18 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
română (RO) (327.6 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
slovenčina (SK) (357.21 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
slovenščina (SL) (375.83 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
Suomi (FI) (335.83 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
svenska (SV) (303.24 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
Product information
Zulvac 1 Ovis : EPAR - Product information
English (EN) (412.77 KB - PDF)
First published: Last updated:
български (BG) (747.04 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
español (ES) (415.86 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
čeština (CS) (625.49 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
dansk (DA) (420.56 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
Deutsch (DE) (442.48 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
eesti keel (ET) (426.62 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
ελληνικά (EL) (744.06 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
français (FR) (441.63 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
hrvatski (HR) (487.06 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
íslenska (IS) (431.83 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
italiano (IT) (439.98 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
latviešu valoda (LV) (612.09 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
lietuvių kalba (LT) (492.04 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
magyar (HU) (645.11 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
Malti (MT) (643.64 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
Nederlands (NL) (428.46 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
norsk (NO) (426.93 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
polski (PL) (637.5 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
português (PT) (424.02 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
română (RO) (523 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
slovenčina (SK) (629.98 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
slovenščina (SL) (619.27 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
Suomi (FI) (412.23 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
svenska (SV) (434.1 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
Latest procedure affecting product information: IB/00017
21/06/2019
Zulvac 1 Ovis : EPAR - All authorised presentations
English (EN) (823.94 KB - PDF)
First published: Last updated:
български (BG) (853.9 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
español (ES) (837.98 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
čeština (CS) (862.38 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
dansk (DA) (806.02 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
Deutsch (DE) (827.27 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
eesti keel (ET) (805.45 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
ελληνικά (EL) (877.4 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
français (FR) (824.01 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
íslenska (IS) (806.86 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
italiano (IT) (801.5 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
latviešu valoda (LV) (843.42 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
lietuvių kalba (LT) (1.38 MB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
magyar (HU) (853.89 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
Malti (MT) (847.1 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
Nederlands (NL) (824.2 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
norsk (NO) (804.7 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
polski (PL) (862.36 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
português (PT) (837.86 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
română (RO) (1.38 MB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
slovenčina (SK) (839.69 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
slovenščina (SL) (858.77 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
Suomi (FI) (824.89 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
svenska (SV) (805.81 KB - PDF)
First published: 10/10/2011Last updated: 01/04/2020
Product details
- Name of medicine
- Zulvac 1 Ovis
- Active substance
- inactivated bluetongue virus, serotype-1
- International non-proprietary name (INN) or common name
- inactivated bluetongue virus, serotype-1
- Species
- Sheep
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI04AA02
Pharmacotherapeutic group
ImmunologicalsTherapeutic indication
Active immunisation of sheep from 1.5 months of age for the prevention of viraemia caused by bluetongue virus, serotypes-1.
Onset of immunity: 21 days after completion of the primary vaccination scheme.
Duration of immunity: 12 months.
Authorisation details
- EMA product number
- EMEA/V/C/002335
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
- 6
Assessment history
Zulvac 1 Ovis : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (535.21 KB - PDF)
First published: Last updated:
Zulvac 1 Ovis-V-C-2335-S-03 : EPAR - Assessment Report - Annual re-assessment
AdoptedReference Number: EMA/120064/2013
English (EN) (615.85 KB - PDF)
First published: Last updated:
Zulvac 1 Ovis : EPAR - Scientific discussion
Reference Number: EMA/457946/2011
English (EN) (305.65 KB - PDF)
First published: Last updated:
CVMP summary of positive opinion for Zulvac 1 Ovis
AdoptedReference Number: EMA/CVMP/291025/2011
English (EN) (432.22 KB - PDF)
First published: Last updated:
News on Zulvac 1 Ovis
This page was last updated on