Scourguard 3 Lyofilisaat en oplosmiddel voor oplossing voor injectie
Scourguard 3 Lyofilisaat en oplosmiddel voor oplossing voor injectie
Authorised
- Escherichia coli, serotype O101:K99 (fimbrial adhesin F5), strain NADC 1471, Inactivated
- Bovine rotavirus A, strain Lincoln, Live
- Bovine coronavirus, strain Hansen, Live
Product identification
Medicine name:
Scourguard 3 Lyofilisaat en oplosmiddel voor oplossing voor injectie
Scourguard 3 Lyophilisat et solvant pour solution injectable
Scourguard 3 Lyophilisat und Lösungsmittel zur Herstellung einer Injektionslösung
Active substance:
- Escherichia coli, serotype O101:K99 (fimbrial adhesin F5), strain NADC 1471, Inactivated
- Bovine rotavirus A, strain Lincoln, Live
- Bovine coronavirus, strain Hansen, Live
Target species:
-
Cattle (pregnant cow)
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Escherichia coli, serotype O101:K99 (fimbrial adhesin F5), strain NADC 1471, Inactivated
-
Bovine rotavirus A, strain Lincoln, Live100000000.00/50% cell culture infectious dose2.00millilitre(s)
-
Bovine coronavirus, strain Hansen, Live7.50/log10 50% cell culture infectious dose2.00millilitre(s)
Pharmaceutical form:
-
Lyophilisate and solvent for solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Cattle (pregnant cow)
-
All relevant tissues0day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI02AI01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Scourguard 3 Lyophilisate and solvent for solution for injection - 1 vial with lyophilisate and 1 vial of 2 ml with solvent
- Scourguard 3 Lyophilisate and solvent for solution for injection - 25 vials with lyophilisate and 25 vials of 2 ml with solvent
- Scourguard 3 Lyophilisate and solvent for solution for injection - 5 vials with lyophilisate and 1 vial of 10 ml with solvent
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
Marketing authorisation date:
Manufacturing sites for batch release:
- Zoetis Belgium
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V126201
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Package Leaflet
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Labelling
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