Veterinary Medicines

CEFASEPTIN 300 MG TABLETS FOR DOGS

Authorised
  • Cefalexin monohydrate
Download as PDF

Product identification

Medicine name:
CEFASEPTIN 300 MG TABLETS FOR DOGS
Cefaseptin 300 mg tablete za pse
Active substance:
  • Cefalexin monohydrate
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Cefalexin monohydrate
    315.60
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01DB01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Package description:

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:
  • Vetoquinol S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetoquinol S.A.
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • DC/V/0521/002
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0415/002
Concerned member states:
  • Austria
  • Belgium
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 4/04/2022
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 4/04/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 4/04/2022
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."