Veterinary Medicines

DUOMYXIN, 3 400 IU/ml / 10 000 IU/ml, Eye drops, powder and solvent for solution for dogs and cats

Authorised
  • NEOMYCIN SULFATE
  • POLYMYXIN B SULFATE
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Product identification

Medicine name:
DUOMYXIN, 3 400 IU/ml / 10 000 IU/ml, Eye drops, powder and solvent for solution for dogs and cats
DUOMYXIN 3400 IU/ml / 10000 IU/ml silmätipat, jauhe ja liuotin liuosta varten
Active substance:
  • NEOMYCIN SULFATE
  • POLYMYXIN B SULFATE
Target species:
  • Cat
  • Dog
Route of administration:
  • Ocular use

Product details

Active substance and strength:
  • NEOMYCIN SULFATE
    17000.00
    international unit(s)
    /
    1.00
    Vial
  • POLYMYXIN B SULFATE
    50000.00
    international unit(s)
    /
    1.00
    Vial
Pharmaceutical form:
  • Eye drops, powder for solution
Withdrawal period by route of administration:
  • Ocular use
    • Cat
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS01AA30
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Finland
Package description:
  • Box of 1 vial of lyophilisate, 1 bottle of 5 ml solvent and 1 dropper

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Domes Pharma
Marketing authorisation date:
Manufacturing sites for batch release:
  • Tubilux Pharma S.p.A.
Responsible authority:
  • Finnish Medicines Agency
Authorisation number:
  • 40405
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0381/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Finland
  • Germany
  • Greece
  • Ireland
  • Italy
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden

Documents

Summary of Product Characteristics

English (PDF)
Published on: 6/02/2024
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Package Leaflet and Labelling

English (PDF)
Published on: 6/02/2024
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Final PuAR Duomyxin NL.V.0381.001.DC v.23102023.pdf

English (PDF)
Published on: 6/02/2024
Download
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