Veterinary Medicines

Enrox Flavour 150 mg Tablets for dogs

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
Enrox Flavour 150 mg Tablets for dogs
Enrox Flavour 150 mg Tablets for dogs
Active substance:
  • Enrofloxacin
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Enrofloxacin
    150.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • United Kingdom (Northern Ireland)
Package description:
  • Polyamide/Aluminium/Polyvinyl chloride film (OPA/Al/PVC), heat sealed with aluminium foil containing 10 tablets / blister. Each cardboard carton contains 100 tablets in 10 blister packs.
  • Polyamide/Aluminium/Polyvinyl chloride film (OPA/Al/PVC), heat sealed with aluminium foil containing 10 tablets / blister. Each cardboard carton contains 10 tablets in 1 blister pack.

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:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
  • Krka-Farma d.o.o.
  • Virbac S.A.
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • Vm 01656/4009
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0423/003
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 15/12/2024
Download

Combined File of all Documents

English (PDF)
Published on: 15/12/2024
Download
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