Nizoral Vet 50 mg Tablet
Nizoral Vet 50 mg Tablet
Not authorised
- Ketoconazole
Product identification
Medicine name:
Nizoral Vet 50 mg Tablet
Nizoral Vet 50 mg Comprimé
Nizoral Vet 50 mg Tablette
Active substance:
- Ketoconazole
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Ketoconazole50.00/milligram(s)1.00Tablet
Pharmaceutical form:
-
Tablet
Withdrawal period by route of administration:
-
Oral use
-
Dog
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ02AB02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Surrendered
Authorised in:
-
Belgium
Package description:
- Nizoral Vet 25 Tablets
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - known active substance (Article 8 of Regulation (EU) 2019/6)
Marketing authorisation holder:
- Janssen Pharmaceutica
Marketing authorisation date:
Manufacturing sites for batch release:
- Janssen Pharmaceutica
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V123794
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Package Leaflet
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