Veterinary Medicines

Imaverol 100 mg/ml Concentrate for Cutaneous Emulsion

Authorised
  • Enilconazole
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Product identification

Medicine name:
Imaverol 100 mg/ml Concentrate for Cutaneous Emulsion
Active substance:
  • Enilconazole
Target species:
  • Cattle
  • Dog
  • Horse
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Enilconazole
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Cutaneous emulsion
Withdrawal period by route of administration:
  • Cutaneous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Horse
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QD01AC90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • 1 litre pack size: Container: white, high density polyethylene bottle with transparent window containing 1 litre of concentrate. Closure: white high density polyethylene screw cap and seal insert lined with polyethylene Dosing device: low density polyethylene measuring cup
  • 100 ml pack size: Container: amber Type III glass bottle containing 100ml of concentrate. Closure: tamper evident and child resistant polypropylene screw cap lines with LDPE Dosing device: polypropylene measuring cup

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Audevard
Marketing authorisation date:
Manufacturing sites for batch release:
  • Mcgregor Cory Limited
  • Lusomedicamenta Sociedade Tecnica Farmaceutica S.A.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10481/001/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

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