Veterinary Medicines

Felimazole 5 mg/ml oral solution for cats

Authorised
  • Thiamazole
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Product identification

Medicine name:
Felimazole 5 mg/ml oral solution for cats
Felimazole 5 mg/ml oplossing voor oraal gebruik voor katten
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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH03BB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:
  • Polyethylene terephthalate (PET) amber bottle of 100 ml, closed with a low density polyethylene (LDPE) plug and a high density polyethylene (HDPE) closure. The veterinary medicinal product is supplied with a 1 ml polyethylene (PE) / polypropylene (PP) measuring syringe for administration of the solution to the animal. The syringe is graduated in 0.25 mg increments up to 5 mg. Each closed bottle and accompanying syringe is contained in a cardboard carton.
  • Polyethylene terephthalate (PET) amber bottle of 30 ml, closed with a low density polyethylene (LDPE) plug and a high density polyethylene (HDPE) closure. The veterinary medicinal product is supplied with a 1 ml polyethylene (PE) / polypropylene (PP) measuring syringe for administration of the solution to the animal. The syringe is graduated in 0.25 mg increments up to 5 mg. Each closed bottle and accompanying syringe is contained in a cardboard carton.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - known active substance (Article 8 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera d.d.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 130688
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0505/004
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Dutch (PDF)
Published on: 27/11/2023
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Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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