- 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The marketing authorisation for this product has been withdrawn at the request of the marketing authorisation holder.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
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Product information
Zulvac 8 Bovis : EPAR - Product Information
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Zulvac 8 Bovis : EPAR - All Authorised presentations
English (EN) (537.75 KB - PDF)
български (BG) (624.22 KB - PDF)
español (ES) (222.31 KB - PDF)
čeština (CS) (433.35 KB - PDF)
dansk (DA) (226.08 KB - PDF)
Deutsch (DE) (183.4 KB - PDF)
eesti keel (ET) (220.22 KB - PDF)
ελληνικά (EL) (432.41 KB - PDF)
français (FR) (221.57 KB - PDF)
italiano (IT) (219.75 KB - PDF)
latviešu valoda (LV) (273.68 KB - PDF)
lietuvių kalba (LT) (420.63 KB - PDF)
magyar (HU) (379.71 KB - PDF)
Malti (MT) (277.41 KB - PDF)
Nederlands (NL) (226.13 KB - PDF)
polski (PL) (271.54 KB - PDF)
português (PT) (380.5 KB - PDF)
română (RO) (255.01 KB - PDF)
slovenčina (SK) (270.57 KB - PDF)
slovenščina (SL) (267.88 KB - PDF)
Suomi (FI) (219.04 KB - PDF)
svenska (SV) (387.87 KB - PDF)
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)
Zulvac 8 Bovis-V-C-145-S-09 : EPAR - Assessment Report - Variation
English (EN) (827.19 KB - PDF)
Zulvac 8 Bovis V-C-145-II-02 : EPAR - Scientific Discussion - Variation
English (EN) (268.93 KB - PDF)
Zulvac 8 Bovis : EPAR - Procedural steps taken before authorisation
English (EN) (200.36 KB - PDF)
Zulvac 8 Bovis : EPAR - Scientific Discussion
English (EN) (389.32 KB - PDF)
Committee for medicinal products for veterinary use summary of opinion: Zulvac 8 Bovis: International Non-proprietary Names (INN): inactivated Bluetongue Virus (BTV) Serotype 8
English (EN) (236.81 KB - PDF)