Zulvac 1+8 Bovis (--) - Suspension for injection
Zulvac 1+8 Bovis (--) - Suspension for injection
Authorised
- Bluetongue virus, serotype 1, strain ALG2006/01 E1, Inactivated
- Bluetongue virus, Serotype 8, strain BTV-8/BEL2006/02, Inactivated
Product identification
Medicine name:
Zulvac 1+8 Bovis (--) - Suspension for injection
Active substance:
- Bluetongue virus, serotype 1, strain ALG2006/01 E1, Inactivated
- Bluetongue virus, Serotype 8, strain BTV-8/BEL2006/02, Inactivated
Target species:
-
Cattle
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Bluetongue virus, serotype 1, strain ALG2006/01 E1, InactivatedPresentation_strength:≥1 RP* Reference:Hse Comments:*Relative potency by a mice potency test compared to a reference vaccine that was shown efficacious in bovine Index:0
-
Bluetongue virus, Serotype 8, strain BTV-8/BEL2006/02, InactivatedPresentation_strength:≥1 RP* Reference:Hse Comments:*Relative potency by a mice potency test compared to a reference vaccine that was shown efficacious in bovine Index:1
Pharmaceutical form:
-
Suspension for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Cattle
-
Not applicable0dayZero days
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI02AA08
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Iceland
-
Ireland
-
Italy
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Latvia
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Liechtenstein
-
Lithuania
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Luxembourg
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Malta
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Netherlands
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Norway
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Poland
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Portugal
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Romania
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Slovakia
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Slovenia
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Spain
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Sweden
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United Kingdom (Northern Ireland)
Package description:
- Packaging:Vial (HDPE), Package_size:1 vial, Content:240 ml (120 doses)
- Packaging:Vial (HDPE), Package_size:1 vial, Content:100 ml (50 doses)
- Packaging:Vial (HDPE), Package_size:1 vial, Content:20 ml (10 doses)
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Zoetis Belgium SA
Marketing authorisation date:
Manufacturing sites for batch release:
- Zoetis Manufacturing & Research Spain S.L.
Responsible authority:
- European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
English (PDF)
Download Published on: 23/11/2022
Bulgarian (PDF)
Published on: 23/11/2022
Croatian (PDF)
Published on: 23/11/2022
Czech (PDF)
Published on: 23/11/2022
Danish (PDF)
Published on: 23/11/2022
Dutch (PDF)
Published on: 23/11/2022
Estonian (PDF)
Published on: 23/11/2022
Finnish (PDF)
Published on: 23/11/2022
French (PDF)
Published on: 23/11/2022
German (PDF)
Published on: 23/11/2022
Greek (PDF)
Published on: 23/11/2022
Hungarian (PDF)
Published on: 23/11/2022
Icelandic (PDF)
Published on: 23/11/2022
Italian (PDF)
Published on: 23/11/2022
Latvian (PDF)
Published on: 23/11/2022
Lithuanian (PDF)
Published on: 23/11/2022
Maltese (PDF)
Published on: 23/11/2022
Norwegian (PDF)
Published on: 23/11/2022
Polish (PDF)
Published on: 23/11/2022
Portuguese (PDF)
Published on: 23/11/2022
Romanian (PDF)
Published on: 23/11/2022
Slovak (PDF)
Published on: 23/11/2022
Slovenian (PDF)
Published on: 23/11/2022
Spanish (PDF)
Published on: 23/11/2022
Swedish (PDF)
Published on: 23/11/2022
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