RISPOVAL 2
RISPOVAL 2
Authorised
- Bovine parainfluenza virus 3, strain RLB103, Live
- ALUMINIUM HYDROXIDE GEL
- Bovine respiratory syncytial virus, strain 375, Live
Product identification
Medicine name:
RISPOVAL 2
Rispoval 2 / BRSV + Pi3 Lyofilisaat en oplosmiddel voor suspensie voor injectie
Rispoval 2 / BRSV + Pi3 Lyophilisat et solvant pour suspension injectable
Rispoval 2 / BRSV + Pi3 Lyophilisat und Lösungsmittel zur Herstellung einer Injektionssuspension
Active substance:
- Bovine parainfluenza virus 3, strain RLB103, Live
- ALUMINIUM HYDROXIDE GEL
- Bovine respiratory syncytial virus, strain 375, Live
Target species:
-
Cattle
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Bovine parainfluenza virus 3, strain RLB103, Live100000.00/log10 50% tissue culture infectious dose1.00Dose
-
ALUMINIUM HYDROXIDE GEL1.00/unit(s)1.00Dose
-
Bovine respiratory syncytial virus, strain 375, Live100000.00/log10 50% tissue culture infectious dose1.00Dose
Pharmaceutical form:
-
Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Cattle
-
All relevant tissues0day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI02AD07
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Available in:
-
Belgium
Package description:
- Cardboard box with 1 vial of lyophilisate (5 doses) and 1 vial of solvent (20 ml)
- Cardboard box with 1 vial of lyophilisate (25 doses) and 1 vial of solvent (100 ml)
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - Known active substance (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-V580497
Date of authorisation status change:
Reference member state:
-
France
Procedure number:
- FR/V/0420/001
Concerned member states:
-
Belgium
-
Croatia
-
Czechia
-
Estonia
-
Germany
-
Hungary
-
Ireland
-
Latvia
-
Lithuania
-
Luxembourg
-
Netherlands
-
Portugal
-
Slovakia
-
Slovenia
-
Spain
-
United Kingdom (Northern Ireland)
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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