Veterinary Medicines

Surolan Vet. øredråber, suspension og kutansuspension 5 + 23 + 0,529 mg/ml

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

Medicine name:
Surolan Vet. 5 + 23 + 0,529 mg/ml øredråber, suspension og kutansuspension
Surolan Vet. øredråber, suspension og kutansuspension 5 + 23 + 0,529 mg/ml
Active substance:
  • Miconazole nitrate
  • Miconazole nitrate
  • POLYMYXIN B SULFATE
  • POLYMYXIN B SULFATE
  • Prednisolone acetate
  • Prednisolone acetate
Target species:
  • Dog
  • Cat
Route of administration:
  • Cutaneous use
  • Auricular use

Product details

Active substance and strength:
  • Miconazole nitrate
    23.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Miconazole nitrate
    23.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • POLYMYXIN B SULFATE
    0.53
    milligram(s)
    /
    1.00
    millilitre(s)
  • POLYMYXIN B SULFATE
    0.53
    milligram(s)
    /
    1.00
    millilitre(s)
  • Prednisolone acetate
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Prednisolone acetate
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Cutaneous/ear drops suspension
Withdrawal period by route of administration:
  • Cutaneous use
    • Dog
    • Cat
  • Auricular 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:
  • Denmark
Available in:
  • Denmark
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lusomedicamenta Sociedade Tecnica Farmaceutica S.A.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 10353
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Danish (, ØREDRÅBER, SUSPENSION OG KUTANSUSPENSION)
Published on: 4/12/2023
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