MARBOGEN COMPLEX ear drops solution for dogs
MARBOGEN COMPLEX ear drops solution for dogs
Authorised
- Marbofloxacin
- Gentamicin sulfate
- Ketoconazole
- Prednisolone
Product identification
Medicine name:
MARBOGEN COMPLEX ear drops solution for dogs
MARBOGEN COMPLEX Ohrentropfen Lösung für Hunde
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:
-
Medicinal product on medical prescription for non-renewable delivery
Authorisation status:
-
Valid
Authorised in:
-
Austria
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:
- Alpha-Vet Kft.
Marketing authorisation date:
Manufacturing sites for batch release:
- Alpha-Vet Kft.
Responsible authority:
- Austrian Agency For Health And Food Safety
Authorisation number:
- 837074
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
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 11/02/2022
Summary of Product Characteristics
This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 11/02/2022
Labelling
This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 11/02/2022
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