Veterinary Medicine Information website

Nobivac Lepto

Not authorised
  • Leptospira interrogans, serovar Portlandvere, strain Ca-12-000, Inactivated
  • Leptospira interrogans, serovar Copenhageni, strain Ic-02-001, Inactivated
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Product identification

Medicine name:
Nobivac Lepto
Active substance:
  • Leptospira interrogans, serovar Portlandvere, strain Ca-12-000, Inactivated
  • Leptospira interrogans, serovar Copenhageni, strain Ic-02-001, Inactivated
Target species:
  • Dog
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Leptospira interrogans, serovar Portlandvere, strain Ca-12-000, Inactivated
    990.00
    unit(s)
    /
    1.00
    millilitre(s)
  • Leptospira interrogans, serovar Copenhageni, strain Ic-02-001, Inactivated
    699.00
    unit(s)
    /
    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:
  • Surrendered
Authorised in:
  • Spain
Package description:
  • Plasic box containing 50 type I glass vials of 1 ml (1 dose) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap
  • Plasic box containing 10 type I glass vials of 1 ml (1 dose) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap
  • Cardboard box containing 50 type I glass vials of 1 ml (1 dose) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap
  • Cardboard box containing 10 type I glass vials of 1 ml (1 dose) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
  • Merck Sharp & Dohme Animal Health S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet International B.V.
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 1514 ESP
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0108/001

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 21/06/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 21/06/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 21/06/2024
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