MARBOGEN COMPLEX ear drops solution for dogs
MARBOGEN COMPLEX ear drops solution for dogs
Authorised
- Marbofloxacin
- Gentamicin sulfate
- Ketoconazole
- Prednisolone
Product identification
Medicine name:
COMPLEXO MARBOGEN - Suspensão de gotas auriculares para cães
MARBOGEN COMPLEX ear drops solution for dogs
Active substance:
- Marbofloxacin
- Gentamicin sulfate
- Ketoconazole
- Prednisolone
Target species:
-
Dog
Route of administration:
-
Auricular use
Product details
Active substance and strength:
-
Marbofloxacin2.04milligram(s)1.00millilitre(s)
-
Gentamicin sulfate2.04milligram(s)1.00millilitre(s)
-
Ketoconazole4.08milligram(s)1.00millilitre(s)
-
Prednisolone1.85milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Ear drops, solution
Withdrawal period by route of administration:
-
Auricular use
-
Dog
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QS02AA30
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Portugal
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:
- Alpha-Vet Kft.
Responsible authority:
- Directorate General For Food And Veterinary
Authorisation number:
- 1015/01/16DFVPT
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
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
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Published on: 28/03/2025
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