Veterinary Medicines

Thyronorm 5 mg/ml Oral Solution for Cats

Authorised
  • Thiamazole
Download as PDF

Product identification

Medicine name:
Thyronorm 5 mg/ml Oral Solution for Cats
Apelka 5 mg/ml Lösung zum Eingeben für Katzen
Active substance:
  • Thiamazole
Target species:
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Thiamazole
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH03BB02
Legal status of supply:
  • Medicinal product on medical prescription for renewable delivery
Authorisation status:
  • Valid
Authorised in:
  • Austria
Package description:

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:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Norbrook Manufacturing Limited
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 836937
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0548/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Luxembourg
  • Norway
  • Portugal
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 24/06/2021
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 16/01/2024
Download

Summary of Product Characteristics

English (PDF)
Published on: 28/01/2022
Download
German (PDF)
Published on: 16/01/2024
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."