HIPRABOVIS SOMNI/Lkt emulsion for injection for cattle
HIPRABOVIS SOMNI/Lkt emulsion for injection for cattle
Authorised
- Mannheimia haemolytica, Serotype A1, Strain 2806, Leucotoxoid
- Histophilus somni, strain Bailie, Inactivated
Product identification
Medicine name:
HIPRABOVIS SOMNI/Lkt emulsion for injection for cattle
Active substance:
- Mannheimia haemolytica, Serotype A1, Strain 2806, Leucotoxoid
- Histophilus somni, strain Bailie, Inactivated
Target species:
-
Cattle
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Mannheimia haemolytica, Serotype A1, Strain 2806, Leucotoxoid2.80/enzyme-linked immunosorbent assay unit1.00Dose
-
Histophilus somni, strain Bailie, Inactivated3.30/other1.00Dose
Pharmaceutical form:
-
Emulsion for injection
Withdrawal period by route of administration:
-
Subcutaneous use
-
Cattle
-
Meat and offal0day
-
Milk0day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI02AB
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- The container consists of 100 ml (50 doses) Type II colourless glassvials, Type I rubber stoppers and aluminium caps.Package sizes:- Cardboard box with one glass bottle of 50 doses with a rubber stopper and aluminium cap.
- The container consists of 20 ml (10 doses) Type I colourless glass vials, Type I rubber stoppers and aluminium caps.Package sizes:- Cardboard box with one glass vial of 10 doses with a rubber stopper and aluminium cap.
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:
- Laboratorios Hipra S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Laboratorios Hipra, S.A.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0186/001
Concerned member states:
-
Austria
-
Belgium
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
Netherlands
-
Poland
-
Portugal
-
Slovakia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
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Labelling
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