Veterinary Medicines

Bovalto Respi 3, Suspension for injection

Authorised
  • Bovine respiratory syncytial virus, strain BIO-24, Inactivated
  • Bovine parainfluenza virus 3, strain BIO-23, Inactivated
  • Mannheimia haemolytica, serotype A1, strain DSM 5283, Inactivated
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Product identification

Medicine name:
Bovalto Respi 3, Suspension for injection
Bovalto injektionsvæske, suspension
Active substance:
  • Bovine respiratory syncytial virus, strain BIO-24, Inactivated
  • Bovine parainfluenza virus 3, strain BIO-23, Inactivated
  • Mannheimia haemolytica, serotype A1, strain DSM 5283, Inactivated
Target species:
  • Cattle
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Bovine respiratory syncytial virus, strain BIO-24, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Bovine parainfluenza virus 3, strain BIO-23, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Mannheimia haemolytica, serotype A1, strain DSM 5283, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Milk
        0
        hour
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AL
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:
  • Glass Vial 10 x 5.0 Dose
  • Plastic Vial 1 x 50.0 Dose
  • Plastic Vial 10 x 5.0 Dose
  • Glass Vial 10 x 5.0 Dose
  • Glass Vial 1 x 25.0 Dose
  • Plastic Vial 1 x 25.0 Dose
  • Glass Vial 1 x 50.0 Dose
  • Plastic Vial 1 x 5.0 Dose
  • Glass Vial 1 x 5.0 Dose
  • Plastic Vial 10 x 5.0 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 Denmark A/S
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 56332
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0128/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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Danish (PDF)
Published on: 3/01/2024
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