Veterinary Medicines

MIPREPOL, oily suspension for dogs and cats

Authorised
  • Miconazole nitrate
  • Prednisolone acetate
  • Polymyxin B
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Product identification

Medicine name:
MIPREPOL, oily suspension for dogs and cats
MIPREPOL® sospensione oleosa per cani e gatti
Active substance:
  • Miconazole nitrate
  • Prednisolone acetate
  • Polymyxin B
Target species:
  • Dog
  • Cat
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Miconazole nitrate
    20.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Prednisolone acetate
    4.48
    milligram(s)
    /
    1.00
    millilitre(s)
  • Polymyxin B
    0.53
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Cutaneous suspension
Withdrawal period by route of administration:
  • Cutaneous use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02CA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • LDPE bottle of 30 ml with squeeze dropper in thermoplastic elastomer and child resistant screw cap in HDPE
  • LDPE bottle of 15 ml with squeeze dropper in thermoplastic elastomer and child resistant screw cap in HDPE
  • LDPE squeeze dropper bottle of 30 ml with a screw cap
  • LDPE squeeze dropper bottle of 15 ml with a screw cap

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:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Janssen Pharmaceutica
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 104700
Date of authorisation status change:
Reference member state:
  • Italy
Procedure number:
  • IT/V/0130/001
Concerned member states:
  • Portugal
  • Spain

Documents

Combined File of all Documents

English (PDF)
Published on: 29/08/2023
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Italian (PDF)
Published on: 22/09/2023
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