Veterinary Medicines

Bovalto Respi Intranasal, Nasal spray, lyophilisate and solvent for suspension

Authorised
  • Bovine respiratory syncytial virus, strain BIO 24/A, Live
  • Bovine parainfluenza virus 3, strain BIO 23/A, Live
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Product identification

Medicine name:
Bovalto Respi Intranasal, Nasal spray, lyophilisate and solvent for suspension
BOVALTO RESPI INTRANASAL, Nasenspray, Lyophilisat und Lösungsmittel zur Herstellung einer Suspension für Rinder
Active substance:
  • Bovine respiratory syncytial virus, strain BIO 24/A, Live
  • Bovine parainfluenza virus 3, strain BIO 23/A, Live
Target species:
  • Cattle
Route of administration:
  • Nasal use

Product details

Active substance and strength:
  • Bovine respiratory syncytial virus, strain BIO 24/A, Live
    7.50
    log10 tissue culture infective dose 50
    /
    1.00
    Dose
  • Bovine parainfluenza virus 3, strain BIO 23/A, Live
    6.00
    log10 tissue culture infective dose 50
    /
    1.00
    Dose
Pharmaceutical form:
  • Nasal spray, lyophilisate and solvent for suspension
Withdrawal period by route of administration:
  • Nasal use
    • Cattle
      • Milk
        0
        hour
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AD07
Legal status of supply:
  • Medicinal product on medical prescription for non-renewable delivery
Authorisation status:
  • Valid
Authorised in:
  • Austria
Package description:
  • Glass Vial 1 x 5.0 Dose
  • Glass Vial 5 x 5.0 Dose
  • Glass Vial 1 x 10.0 Dose
  • Glass Vial 5 x 1.0 Dose

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:
  • Boehringer Ingelheim Animal Health France
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 838159
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0141/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 29/11/2022
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 29/11/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 29/11/2022
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