Veterinary Medicines

Normazole 5 mg/ml Oral Solution for Cats

Authorised
  • Thiamazole
Download as PDF

Product identification

Medicine name:
APELKA 5 mg/ml soluție orală pentru pisici
Normazole 5 mg/ml Oral Solution for Cats
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:
  • Romania
Available in:
  • Romania
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 Limited
  • Norbrook Laboratories (Ireland) Limited
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 210087
Date of authorisation status change:
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
Download

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Romanian (PDF)
Published on: 4/10/2024
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."