Veterinary Medicines

Surolan

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

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

Product details

Active substance and strength:
  • Miconazole nitrate
    23.00
    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)
Pharmaceutical form:
  • Ear drops, suspension
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS03CA02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Available in:
  • Germany
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis reviewed according to Acquis communautaire
Marketing authorisation holder:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lusomedicamenta Sociedade Tecnica Farmaceutica S.A.
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 6762218.00.00
Date of authorisation status change:

Documents

Combined File of all Documents

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German (PDF)
Published on: 7/11/2024
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