Veterinary Medicines

Normazole 5 mg/ml Oral Solution for Cats

Authorised
  • Thiamazole
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Product identification

Medicine name:
Normazole 5 mg/ml Oral Solution for Cats
Apelka 5 mg/ml Roztwór doustny
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:
  • Poland
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 Laboratories (Ireland) Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2574
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0604/001
Concerned member states:
  • Poland
  • Romania
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Polish (PDF)
Published on: 16/03/2022
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Labelling

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