Veterinary Medicines

Bovilis Bovipast RSP suspension for injection for cattle

Authorised
  • Bovine respiratory syncytial virus, strain EV 908, Inactivated
  • Bovine parainfluenza virus 3, strain SF-4, Inactivated
  • Mannheimia haemolytica, serotype A1, strain M4/1, Inactivated
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Product identification

Medicine name:
Bovilis Bovipast RSP, sospensione iniettabile per bovini
Bovilis Bovipast RSP, sospensione iniettabile per bovini
Bovilis Bovipast RSP suspension for injection for cattle
Active substance:
  • Bovine respiratory syncytial virus, strain EV 908, Inactivated
  • Bovine parainfluenza virus 3, strain SF-4, Inactivated
  • Mannheimia haemolytica, serotype A1, strain M4/1, Inactivated
Target species:
  • Cattle
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Bovine respiratory syncytial virus, strain EV 908, Inactivated
    281838.00
    unit(s)
    /
    5.00
    millilitre(s)
  • Bovine parainfluenza virus 3, strain SF-4, Inactivated
    70794.60
    unit(s)
    /
    5.00
    millilitre(s)
  • Mannheimia haemolytica, serotype A1, strain M4/1, Inactivated
    100000.00
    unit(s)
    /
    5.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AL04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • 50 ml bottles of type I glass (10 doses), Ph. Eur., closed with injection stoppers type I rubber, Ph. Eur., sealed with an aluminium crimp 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:
  • MSD Animal Health S.r.l.
Marketing authorisation date:
Manufacturing sites for batch release:
  • INTERVET INTERNATIONAL B.V.
Responsible authority:
  • MdS
Authorisation number:
  • 103003
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0537/001
Concerned member states:
  • Belgium
  • Denmark
  • Finland
  • Greece
  • Italy
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Italian (PDF)
Published on: 20/03/2023
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