Veterinary Medicines

SUROLAN, ear drops and cutaneous suspension for dogs and cats

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

Medicine name:
SUROLAN, капки за уши и суспензия за кожа за кучета и котки
SUROLAN, ear drops and cutaneous suspension for dogs and cats
Active substance:
  • POLYMYXIN B SULFATE
  • Prednisolone acetate
  • Miconazole nitrate
Target species:
  • Cat
  • Dog
Route of administration:
  • Auricular use

Product details

Active substance and strength:
  • POLYMYXIN B SULFATE
    0.53
    milligram(s)
    /
    1.00
    millilitre(s)
  • Prednisolone acetate
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Miconazole nitrate
    23.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Ear drops, suspension
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QD01AC52
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Available in:
  • Bulgaria
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lusomedicamenta Sociedade Tecnica Farmaceutica S.A.
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-2108
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 24/02/2023
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Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 24/02/2023
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