Veterinary Medicines

Nisamox 50 mg Tablets for Dogs and Cats

Authorised
  • Amoxicillin trihydrate
  • Potassium clavulanate
Download as PDF

Product identification

Medicine name:
Nisamox 50 mg Tablets for Dogs and Cats
Nisamox 50 mg compresse per cani e gatti
Active substance:
  • Amoxicillin trihydrate
  • Potassium clavulanate
Target species:
  • Dog
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    40.00
    milligram(s)
    /
    1.00
    Tablet
  • Potassium clavulanate
    10.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CR02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • box containing 500 tablets (50 blister)
  • box containing 20 tablets (2 blister)
  • box containing 100 tablets (10 blister)
  • bottle containing 500 tablets
  • bottle containing 100 tablets

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:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Norbrook Laboratories (Ireland) Limited
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 103672
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0348/001
Concerned member states:
  • Italy

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Italian (PDF)
Published on: 2/02/2024
Download

Summary of Product Characteristics

English (PDF)
Published on: 5/04/2023
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."