Veterinary Medicines

RISPOVAL RS

Authorised
  • Bovine respiratory syncytial virus, strain RB94, Live
  • Water for injection
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Product identification

Medicine name:
RISPOVAL RS
Active substance:
  • Bovine respiratory syncytial virus, strain RB94, Live
  • Water for injection
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Bovine respiratory syncytial virus, strain RB94, Live
    31622800.00
    cell culture infective dose 50
    /
    1.00
    Dose
  • Water for injection
    1.00
    other
    /
    1.00
    Dose
Pharmaceutical form:
  • Powder for suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AD04
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • The vaccine is filled in 25 dose glass vials type I.The diluent is filled in 25-dose (50 ml) vials.Both vials have a butyl rubber stopper and an aluminium cap.
  • The vaccine is filled in 5 dose glass vials type I.The diluent is filled in 5-dose (10 ml) vials.Both vials have a butyl rubber stopper and an aluminium cap.
  • The vaccine is filled in 1 dose glass vials type I.The diluent is filled in 1-dose (2 ml) vials.Both vials have a butyl rubber stopper and an aluminium cap.

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 S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10387/063/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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