Veterinary Medicines

Spizobactin 3,000,000 IU / 500 mg chewable tablets for dogs

Authorised
  • Metronidazole
  • Spiramycin
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Product identification

Medicine name:
Spizobactin 3,000,000 IU / 500 mg chewable tablets for dogs
Spizobactin 3.000.000 IE / 500 mg Kautabletten für Hunde
Active substance:
  • Metronidazole
  • Spiramycin
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Metronidazole
    500.00
    milligram(s)
    /
    1.00
    Tablet
  • Spiramycin
    714.28
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01RA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Package description:
  • (ID10) 100 Chewable tablets: cardboard box with 10 cardboard boxes each with 1 Blister (PolyVinyl Chloride, PolyEthylene, PolyVinylidene Chloride) with 10 Chewable tablets, closed with foil (Aluminium)
  • (ID3) 30 Chewable tablets: cardoboard box with 3 Blisters (PolyVinyl Chloride, PolyEthylene, PolyVinylidene Chloride) each with 10 Chewable tablets, closed with foil (Aluminium)
  • (ID2) 20 Chewable tablets: cardboard box with 2 Blisters (PolyVinyl Chloride, PolyEthylene, PolyVinylidene Chloride) each with 10 Chewable tablets, closed with foil (Aluminium)
  • (ID1) 10 Chewable tablets: cardboard box with 1 Blister (PolyVinyl Chloride, PolyEthylene, PolyVinylidene Chloride) with 10 Chewable tablets, closed with foil (Aluminium)
  • (ID11) 100 Chewable tablets: cardboard box with 1 Blister (PolyVinyl Chloride, PolyEthylene, PolyVinylidene Chloride) with 10 Chewable tablets, closed with foil (Aluminium)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) 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.
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 402380.00.00
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0171/003
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: 15/01/2024
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 19/11/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 19/11/2024
Download

2402380-paren-20171010.rtf

English (RTF)
Published on: 19/11/2024
Download
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