Veterinary Medicines

Dicortineff-Vet (2500 j.m. + 25 j.m. + 1 mg)/ml Krople do oczu i uszu, zawiesina

Authorised
  • Fludrocortisone acetate
  • Gramicidin
  • NEOMYCIN SULFATE
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Product identification

Medicine name:
Dicortineff-Vet (2500 j.m. + 25 j.m. + 1 mg)/ml Krople do oczu i uszu, zawiesina
Active substance:
  • Fludrocortisone acetate
  • Gramicidin
  • NEOMYCIN SULFATE
Target species:
  • Cat
  • Dog
Route of administration:
  • Auricular use
  • Ocular use

Product details

Active substance and strength:
  • Fludrocortisone acetate
    1.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Gramicidin
    25.00
    international unit(s)
    /
    1.00
    millilitre(s)
  • NEOMYCIN SULFATE
    2500.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Ear/eye drops, suspension
Withdrawal period by route of administration:
  • Auricular use
    • Cat
    • Dog
  • Ocular use
    • Cat
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS03CA05
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 0346
Date of authorisation status change:

Documents

Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 16/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 16/03/2022
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