Veterinary Medicines

Noroclav 500 mg Palatable Tablets for Dogs

Authorised
  • Amoxicillin trihydrate
  • Potassium clavulanate
Download as PDF

Product identification

Medicine name:
Noroclav 500 mg Palatable Tablets for Dogs
Noroclav 500 mg comprimidos palatáveis para cães
Active substance:
  • Amoxicillin trihydrate
  • Potassium clavulanate
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    459.22
    milligram(s)
    /
    1.00
    Tablet
  • Potassium clavulanate
    119.13
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CR02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
Available in:
  • Portugal
Package description:
  • Aluminium/aluminium blister strips, each containing 5 tablets. Cartons of 10 tablets.
  • Aluminium/aluminium blister strips, each containing 5 tablets. Cartons of 20 tablets.
  • Aluminium/aluminium blister strips, each containing 5 tablets. Cartons of 25 tablets.
  • Aluminium/aluminium blister strips, each containing 5 tablets. Cartons of 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 Manufacturing Limited
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 027/01/07RFVPT
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0547/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • France
  • Luxembourg
  • Netherlands
  • Norway
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Portuguese (PDF)
Published on: 11/04/2022
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."