Veterinary Medicines

LEPTOVAC BIO

Authorised
  • Leptospira interrogans, serogroup Pomona, Inactivated
  • LEPTOSPIRA ICTEROHAEMORRHAGIAE
  • Leptospira kirschneri, Serogroup Grippotyphosa, Inactivated
  • Leptospira santarosai, Serogroup Tarassovi, Inactivated
  • Leptospira interrogans, serogroup Australis, serovar Bratislava, Inactivated
  • Leptospira interrogans, serogroup Sejroe, serovar Wolffi, Inactivated
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Product identification

Medicine name:
LEPTOVAC BIO
Active substance:
  • Leptospira interrogans, serogroup Pomona, Inactivated
  • LEPTOSPIRA ICTEROHAEMORRHAGIAE
  • Leptospira kirschneri, Serogroup Grippotyphosa, Inactivated
  • Leptospira santarosai, Serogroup Tarassovi, Inactivated
  • Leptospira interrogans, serogroup Australis, serovar Bratislava, Inactivated
  • Leptospira interrogans, serogroup Sejroe, serovar Wolffi, Inactivated
Target species:
  • Cattle
  • Horse
  • Sheep
  • Pig
Route of administration:
  • Subcutaneous use
  • Intramuscular use

Product details

Active substance and strength:
  • Leptospira interrogans, serogroup Pomona, Inactivated
  • LEPTOSPIRA ICTEROHAEMORRHAGIAE
  • Leptospira kirschneri, Serogroup Grippotyphosa, Inactivated
  • Leptospira santarosai, Serogroup Tarassovi, Inactivated
  • Leptospira interrogans, serogroup Australis, serovar Bratislava, Inactivated
  • Leptospira interrogans, serogroup Sejroe, serovar Wolffi, Inactivated
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
    • Horse
    • Sheep
  • Intramuscular use
    • Pig
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AB03
  • QI04AB
  • QI05AB
  • QI09AB
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Biosfera Farm EOOD
Marketing authorisation date:
Manufacturing sites for batch release:
  • Pasteur Filiala Filipesti S.A.
Responsible authority:
  • BFSA
Authorisation number:
  • 0022-3018
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 3/05/2023
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Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 8/06/2022
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