Veterinary Medicines

Nobivac Lepto 2 Suspension for Injection for Dogs

Authorised
  • Leptospira interrogans, serovar Portlandvere, strain Ca-12-000, Inactivated
  • Leptospira interrogans, serovar Copenhageni, strain 820K, Inactivated
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Product identification

Medicine name:
Nobivac Lepto 2 Suspension for Injection for Dogs
Active substance:
  • Leptospira interrogans, serovar Portlandvere, strain Ca-12-000, Inactivated
  • Leptospira interrogans, serovar Copenhageni, strain 820K, Inactivated
Target species:
  • Dog
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Leptospira interrogans, serovar Portlandvere, strain Ca-12-000, Inactivated
    1755.00
    enzyme-linked immunosorbent assay unit
    /
    1.00
    millilitre(s)
  • Leptospira interrogans, serovar Copenhageni, strain 820K, Inactivated
    1277.00
    enzyme-linked immunosorbent assay unit
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI07AB01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • Type I glass vial(s) of 1 ml closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.Pack sizes:Cardboard or plastic box with 10 vials of 1 ml (1 dose).
  • Type I glass vial(s) of 1 ml closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.Pack sizes:Cardboard or plastic box with 50 vials of 1 ml (1 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:
  • Intervet (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet International B.V.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10996/169/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 10/11/2024
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