Veterinary Medicines

Chanear

Authorised
  • Miconazole nitrate
  • Prednisolone acetate
  • POLYMYXIN B SULFATE
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Product identification

Medicine name:
Chanear
Chanear
Active substance:
  • Miconazole nitrate
  • Prednisolone acetate
  • POLYMYXIN B SULFATE
Target species:
  • Dog
  • Cat
Route of administration:
  • Auricular use
  • Cutaneous use

Product details

Active substance and strength:
  • Miconazole nitrate
    23.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Prednisolone acetate
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • POLYMYXIN B SULFATE
    5500.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Ear drops, suspension
Withdrawal period by route of administration:
  • Auricular use
    • Dog
    • Cat
  • 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:
  • Ireland
Package description:
  • 30 ml white low-density polyethylene squeeze dropper bottle with a white, high-density polyethylene cap (screw fit), and a white, low-density polyethylene dropper.
  • 15 ml white low-density polyethylene squeeze dropper bottle with a white, high-density polyethylene cap (screw fit), and a white, low-density polyethylene dropper.

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:
  • Chanelle Pharmaceuticals Manufacturing Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Chanelle Pharmaceuticals Manufacturing Limited
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10987/169/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0665/001
Concerned member states:
  • Belgium
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Romania
  • Spain

Documents

Summary of Product Characteristics

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