Veterinary Medicine Information website

Spizobactin 750,000 IU / 125 mg chewable tablets for dogs

Authorised
  • Metronidazole
  • Spiramycin
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Product identification

Medicine name:
Spizobactin 750,000 IU / 125 mg chewable tablets for dogs
Active substance:
  • Metronidazole
  • Spiramycin
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Metronidazole
    125.00
    milligram(s)
    /
    1.00
    Tablet
  • Spiramycin
    178.57
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01RA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
Package description:
  • (ID11) 100 Chewable tablet: Box (cardboard) with 10 Blister (aluminium) each with 10 Chewable tablet, closed with Foil (polyvinyl chloride, polyethylene, polyvinylidene chloride)
  • (ID1) 10 Chewable tablet: Box (cardboard) with 1 Blister (aluminium) with 10 Chewable tablet, closed with Foil (polyvinyl chloride, polyethylene, polyvinylidene chloride)
  • (ID10) 100 Chewable tablet: Box (cardboard) with 10 Box (cardboard) each with 1 Blister (aluminium) with 10 Chewable tablet, closed with Foil (polyvinyl chloride, polyethylene, polyvinylidene chloride)
  • (ID3) 30 Chewable tablet: Box (cardboard) with 3 Blister (aluminium) each with 10 Chewable tablet, closed with Foil (polyvinyl chloride, polyethylene, polyvinylidene chloride)
  • (ID2) 20 Chewable tablet: Box (cardboard) with 2 Blister (aluminium) each with 10 Chewable tablet, closed with Foil (polyvinyl chloride, polyethylene, polyvinylidene chloride)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Le Vet. Beheer B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lelypharma B.V.
  • Genera d.d.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/044/DC/17-S
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0171/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 20/03/2026
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Slovak (PDF)
Published on: 12/08/2024
Updated on: 14/08/2024
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