Veterinary Medicines

Levoroxin 400 microgram Tablets for dogs and cats

Authorised
  • Levothyroxine sodium
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Product identification

Medicine name:
Levoroxin 400 microgram Tablets for dogs and cats
Thyron Vet 400 microgrammes comprimés pour chiens et chats
Thyron Vet 400 microgram tabletten voor honden en katten
Thyron Vet 400 μg Tabletten für Hunde und Katzen
Active substance:
  • Levothyroxine sodium
Target species:
  • Dog
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Levothyroxine sodium
    400.00
    microgram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH03AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • Cardboard box with 250 tablets (25 Aluminium-PVC/Alu/oPA blisters of 10 tablets)
  • Cardboard box with 100 tablets (10 Aluminium-PVC/Alu/oPA blisters of 10 tablets)
  • Cardboard box with 30 tablets (3 Aluminium-PVC/Alu/oPA blisters of 10 tablets)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • CP-Pharma Handelsgesellschaft mbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • CP-Pharma Handelsgesellschaft mbH
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V662416
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0395/002
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden

Documents

Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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NLV0395001-004DC Thyron Vet_Final PuAR.pdf

English (PDF)
Published on: 4/06/2024
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