Ketofungol 200 mg Tablet
Ketofungol 200 mg Tablet
Authorised
- Ketoconazole
Product identification
Medicine name:
Ketofungol 200 mg Tablet
Ketofungol 200 mg Comprimé
Ketofungol 200 mg Tablette
Active substance:
- Ketoconazole
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Ketoconazole200.00/milligram(s)1.00Tablet
Pharmaceutical form:
-
Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ02AB02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Available in:
-
Belgium
Package description:
- Ketofungol 6 Blisters with 10 Tablets
- Ketofungol 2 Blisters with 10 Tablets
- Ketofungol 1 Blister with 10 Tablets
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6)
Marketing authorisation holder:
- Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
- Lusomedicamenta Sociedade Tecnica Farmaceutica S.A.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V386513
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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Labelling
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