Veterinary Medicines

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

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

Medicine name:
Bovilis INtranasal RSP Live nasal spray, lyophilisate and solvent for suspension for cattle
Bovilis INtranasal RSP Live, спрей за нос, лиофилизат и разтворител за суспензия за говеда
Active substance:
  • Bovine respiratory syncytial virus, strain Jencine-2013, Live
  • Bovine parainfluenza virus 3, strain INT2-2013, Live
Target species:
  • Cattle
Route of administration:
  • Nasal use

Product details

Active substance and strength:
  • Bovine respiratory syncytial virus, strain Jencine-2013, Live
    100000.00
    unit(s)
    /
    1.00
    Dose
  • Bovine parainfluenza virus 3, strain INT2-2013, Live
    63095.70
    unit(s)
    /
    1.00
    Dose
Pharmaceutical form:
  • Nasal spray, suspension
Withdrawal period by route of administration:
  • Nasal use
    • Cattle
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AD07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Package description:
  • Cardboard box with 50 doses of lyophilisate and cardboard box with 100 ml of solvent
  • Cardboard box with 25 doses of lyophilisate and cardboard box with 50 ml of solvent
  • Cardboard box 5 x 5 doses of lyophilisate and 5 x 10 ml of solvent
  • Cardboard box 5 x 10 doses of lyophilisate and 5 x 20 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.

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:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-2905
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

Combined File of all Documents

English (PDF)
Published on: 25/03/2024
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Bulgarian (PDF)
Published on: 29/11/2022
Download
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