Veterinary Medicines

Bovilis INtranasal RSP Live nasal spray, lyophilisate and solvent for suspension for cattle

Authorised
  • Bovine parainfluenza virus 3, strain INT2-2013, Live
  • Bovine respiratory syncytial virus, strain Jencine-2013, Live
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Product identification

Medicine name:
Bovilis INtranasal RSP Live nasal spray, lyophilisate and solvent for suspension for cattle
Bovilis RSP Live Vet. næsespray, lyofilisat og solvens til suspension
Active substance:
  • Bovine parainfluenza virus 3, strain INT2-2013, Live
  • Bovine respiratory syncytial virus, strain Jencine-2013, Live
Target species:
  • Cattle
Route of administration:
  • Nasal use

Product details

Active substance and strength:
  • Bovine parainfluenza virus 3, strain INT2-2013, Live
    4.80
    log10 50% tissue culture infectious dose
    /
    2.00
    millilitre(s)
  • Bovine respiratory syncytial virus, strain Jencine-2013, Live
    5.00
    log10 50% tissue culture infectious dose
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Nasal spray, suspension
Withdrawal period by route of administration:
  • Nasal use
    • Cattle
      • Meat and offal
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AD07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • Cardboard box 5 x 5 doses of lyophilisate and 5 x 10 ml of solvent
  • Cardboard box with 20 doses of lyophilisate and cardboard box with 40 ml of solvent
  • Cardboard box with 1 dose of lyophilisate and 2 ml of solvent.
  • Cardboard box 5 x 1 dose of lyophilisate and 5 x 2 ml of solvent
  • Cardboard box 5 doses of lyophilisate and 10 ml of solvent.
  • Cardboard box 10 doses of lyophilisate and 20 ml of solvent.
  • Cardboard box with 10 doses of lyophilisate and cardboard box with 20 ml solvent
  • Cardboard box with 20 doses of lyophilisate and 40 ml of solvent

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:
  • Intervet International B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet International B.V.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 61208
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0257/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Danish (, NÆSESPRAY, LYOFILISAT OG SOLVENS TIL SUSPENSION)
Published on: 26/08/2024
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Combined File of all Documents

English (PDF)
Published on: 25/03/2024
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