Veterinary Medicines

HIPRABOVIS SOMNI/Lkt emulsion for injection for cattle

Authorised
  • Mannheimia haemolytica, serotype A1, strain NL 1009, leucotoxoid
  • Histophilus somni, strain Bailie, Inactivated
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Product identification

Medicine name:
HIPRABOVIS SOMNI/Lkt emulsion for injection for cattle
HIPRABOVIS SOMNI/Lkt
Active substance:
  • Mannheimia haemolytica, serotype A1, strain NL 1009, 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 NL 1009, leucotoxoid
    2.80
    enzyme-linked immunosorbent assay unit
    /
    1.00
    Dose
  • Histophilus somni, strain Bailie, Inactivated
    3.30
    other
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AB
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
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:
  • Paul-Ehrlich-Institut
Authorisation number:
  • PEI.V.03470.01.1
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)

Documents

Combined File of all Documents

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German (PDF)
Published on: 3/02/2025
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