Veterinary Medicines

MARBOGEN COMPLEX ear drops solution for dogs

Authorised
  • Prednisolone
  • Ketoconazole
  • Gentamicin sulfate
  • Marbofloxacin
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Product identification

Medicine name:
MARBOGEN COMPLEX ear drops solution for dogs
MARBOGEN COMPLEX picături auriculare, soluție pentru câini
Active substance:
  • Prednisolone
  • Ketoconazole
  • Gentamicin sulfate
  • Marbofloxacin
Target species:
  • Dog
Route of administration:
  • Auricular use

Product details

Active substance and strength:
  • Prednisolone
    1.85
    milligram(s)
    /
    1.00
    millilitre(s)
  • Ketoconazole
    4.08
    milligram(s)
    /
    1.00
    millilitre(s)
  • Gentamicin sulfate
    2.04
    milligram(s)
    /
    1.00
    millilitre(s)
  • Marbofloxacin
    2.04
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Ear drops, solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02AA30
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:
  • 10 ml white LDPE bottle assembled with white LDPE dropper and closed with white HDPE cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Fixed combination application (Article 13b of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Alphavet Zrt.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alphavet Zrt.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 210204
Date of authorisation status change:
Reference member state:
  • Hungary
Procedure number:
  • HU/V/0123/001
Concerned member states:
  • Austria
  • Bulgaria
  • Cyprus
  • Greece
  • Italy
  • Latvia
  • Lithuania
  • Malta
  • Portugal
  • Romania
  • Slovakia
  • Slovenia

Documents

Combined File of all Documents

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Romanian (PDF)
Published on: 25/02/2025
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