Veterinary Medicines

Z-Itch 40 mg/ml pour-on solution

Authorised
  • Permethrin
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Product identification

Medicine name:
Z-Itch 40 mg/ml pour-on solution
Z-Itch 40 mg/ml pour-on solution
Active substance:
  • Permethrin
Target species:
  • Donkey
  • Horse (non food-producing)
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Permethrin
    40.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Pour-on solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AC04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • Container size: 250 ml.Container material: Natural, high density polyethylene bottle in a cardboard box.Closure: White, polypropylene screw fit cap with induction seal.Dosing device: Integral graduated dispensing chamber.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Floris Holding B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Floris Veterinaire Producten B.V.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA22969/001/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0626/001
Concerned member states:
  • Belgium
  • Denmark
  • Germany
  • Italy
  • Poland
  • Portugal
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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