Veterinary Medicines

Thyronorm 5 mg/ml Oral Solution for Cats

Authorised
  • Thiamazole
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Product identification

Medicine name:
Thyronorm 5 mg/ml Oral Solution for Cats
Apelka 5 mg/ml solução oral para gatos
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:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
Available in:
  • Portugal
Package description:
  • 30 ml presentations filled into amber polyethylene terephthalate (PET) screw bottles with HDPE/LDPE child resistant caps. The product is supplied with a 1 ml polyethylene/polypropylene measuring syringe. The syringe is graduated in 0.5 mg increments up to 5 mg.
  • 100 ml presentations filled into amber polyethylene terephthalate (PET) screw bottles with HDPE/LDPE child resistant caps. The product is supplied with a 1 ml polyethylene/polypropylene measuring syringe. The syringe is graduated in 0.5 mg increments up to 5 mg.

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 Manufacturing Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 1003/01/16DFVPT
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

Summary of Product Characteristics

English (PDF)
Published on: 9/03/2025
Download

Combined File of all Documents

English (PDF)
Published on: 9/03/2025
Download
Portuguese (PDF)
Published on: 26/03/2025
Download
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