Veterinary Medicines

Zobuxa 100 mg tablets for dogs

Authorised
  • Enrofloxacin
Download as PDF

Product identification

Medicine name:
Zobuxa 100 mg tablets for dogs
Zobuxa 100 mg
Active substance:
  • Enrofloxacin
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Enrofloxacin
    100.00
    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:
  • Germany
Available in:
  • Germany
Package description:
  • (ID2) 100 Tablet: unspecified outer container with 1 Blister (Aluminium) with 100 Tablet
  • (ID1) 10 Tablet: unspecified outer container with 1 Blister (Aluminium) with 10 Tablet

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:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Elanco France S.A.S
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 401491.02.00
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0197/003
Concerned member states:
  • Austria
  • Czechia
  • Hungary
  • Ireland
  • Italy
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 7/02/2022
Download

2401493-paren-20180424.rtf

English (RTF)
Published on: 15/01/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."