ALPHADERM Plus cutaneous spray solution for dogs
ALPHADERM Plus cutaneous spray solution for dogs
Authorised
- Marbofloxacin
- Ketoconazole
- Prednisolone
Product identification
Medicine name:
ALPHADERM Plus cutaneous spray solution for dogs
ALPHADERM Plus спрей за кожа за кучета
Active substance:
- Marbofloxacin
- Ketoconazole
- Prednisolone
Target species:
-
Dog
Route of administration:
-
External use
Product details
Active substance and strength:
-
Marbofloxacin1.03milligram(s)1.00millilitre(s)
-
Ketoconazole2.04milligram(s)1.00millilitre(s)
-
Prednisolone0.93milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Cutaneous spray
Withdrawal period by route of administration:
-
External use
- Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QD07CA03
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Bulgaria
Package description:
- 100 ml PET bottle with a spray pump in cardboard box
- 30 ml PET bottle with a spray pump in cardboard box
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:
- Bulgarian Food Safety Authority
Authorisation number:
- 0022-2139
Date of authorisation status change:
Reference member state:
-
Hungary
Procedure number:
- HU/V/0117/001
Concerned member states:
-
Austria
-
Bulgaria
-
Czechia
-
Italy
-
Romania
-
Slovakia
-
Slovenia
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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in another language below.
Bulgarian (PDF)
Published on: 23/03/2022
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