Veterinary Medicines

Nobivac Lepto 2 Suspension for Injection for Dogs

Authorised
  • Leptospira interrogans, serogroup Canicola, serovar Portland-vere, strain Ca-12-000, Inactivated
  • Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Copenhageni, strain 820K, Inactivated
Download as PDF

Product identification

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

Product details

Active substance and strength:
  • Leptospira interrogans, serogroup Canicola, serovar Portland-vere, strain Ca-12-000, Inactivated
    900.00
    enzyme-linked immunosorbent assay unit
    /
    1.00
    Dose
  • Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Copenhageni, strain 820K, Inactivated
    750.00
    enzyme-linked immunosorbent assay unit
    /
    1.00
    Dose
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Dog
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:
  • HPRA
Authorisation number:
  • VPA10996/169/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 8/04/2022
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."