Veterinary Medicines

SUROLAN ušné kvapky a dermálna suspenzia

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

Medicine name:
SUROLAN ušné kvapky a dermálna suspenzia
Active substance:
  • Miconazole nitrate
  • POLYMYXIN B SULFATE
  • Prednisolone acetate
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)
  • POLYMYXIN B SULFATE
    5500.00
    international unit(s)
    /
    1.00
    millilitre(s)
  • Prednisolone acetate
    5.00
    milligram(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:
  • QD01AC52
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
Available in:
  • Slovakia
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:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/084/92-S
Date of authorisation status change:

Documents

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Slovak (PDF)
Published on: 11/08/2023
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