Bovalto Respi 3, Suspension for injection
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
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, Inactivated1.00relative potency1.00Dose
-
Bovine parainfluenza virus 3, strain BIO-23, Inactivated1.00relative potency1.00Dose
-
Mannheimia haemolytica, serotype A1, strain DSM 5283, Inactivated1.00relative potency1.00Dose
Pharmaceutical form:
-
Suspension for injection
Withdrawal period by route of administration:
-
Subcutaneous use
- Cattle
-
Milk0hour
-
Meat and offal0day
-
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 10 x 5.0 Dose
- Glass Vial 1 x 25.0 Dose
- Plastic Vial 1 x 5.0 Dose
- Glass Vial 1 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 50.0 Dose
- Plastic Vial 1 x 25.0 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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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in another language below.
Danish (PDF)
Published on: 3/01/2024
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