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SUROLAN DROPS 23mg/ml, 5500IU/ml, 5mg/ml ωτικές σταγόνες σε εναιώρημα και δερματικό εναιώρημα για σκύλους και γάτες

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

Medicine name:
SUROLAN DROPS 23mg/ml, 5500IU/ml, 5mg/ml ωτικές σταγόνες σε εναιώρημα και δερματικό εναιώρημα για σκύλους και γάτες
Active substance:
  • Prednisolone acetate
  • POLYMYXIN B SULFATE
  • Miconazole nitrate
Target species:
  • Dog
  • Cat
Route of administration:
  • Auricular use
  • Cutaneous use

Product details

Active substance and strength:
  • Prednisolone acetate
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • POLYMYXIN B SULFATE
    0.53
    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:
  • Cyprus
Available in:
  • Cyprus
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 8(3) of Directive No 2001/83/EC)
Marketing authorisation holder:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lusomedicamenta Sociedade Tecnica Farmaceutica S.A.
Responsible authority:
  • Veterinary Services, Ministry Of Agriculture, Natural Resources And Environment
Authorisation number:
  • CY00039V
Date of authorisation status change:

Documents

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Published on: 29/05/2023
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