Veterinary Medicines

Forthyron 200 Microgram Flavoured Tablet

Authorised
  • Levothyroxine sodium
Download as PDF

Product identification

Medicine name:
Forthyron 200 Microgram Flavoured Tablet
Forthyron Flavoured 200 mcg Tabletka
Active substance:
  • Levothyroxine sodium
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Levothyroxine sodium
    200.00
    microgram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH03AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:
  • 10 tablets in a blister [Aluminium (20micrometre) - PVC_PE_PVDC (250_30_90) white], 25 blisters per carton
  • 10 tablets in a blister [Aluminium (20micrometre) - PVC_PE_PVDC (250_30_90) white], 5 blisters per carton

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:
  • Eurovet Animal Health B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dales Pharmaceuticals Limited
  • Eurovet Animal Health B.V.
  • Genera d.d.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2223
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0286/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • 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.
Polish (PDF)
Published on: 4/02/2022
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/05/2022
Download

Combined File of all Documents

English (PDF)
Published on: 20/06/2022
Updated on: 21/06/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 6/02/2023
Download

PAR 108733.pdf

English (PDF)
Published on: 20/06/2022
Updated on: 21/06/2022
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."