Itrafungol 10 mg/ml Oral Solution
Itrafungol 10 mg/ml Oral Solution
Authorised
- Itraconazole
Product identification
Medicine name:
Itrafungol 10 mg/ml Oral Solution
Itrafungol 10 mg/ml Oral Solution
Active substance:
- Itraconazole
Target species:
-
Cat
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Itraconazole10.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Oral solution
Withdrawal period by route of administration:
-
Oral use
-
Cat
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ02AC02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Ireland
Available in:
-
Ireland
Package description:
- Amber glass bottle (type III) containing 52 ml oral solution, closed with a child resistant polypropylene screw cap with a LDPE insert packed in a cardboard box with a graduated dosing syringe.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Virbac
Marketing authorisation date:
Manufacturing sites for batch release:
- Lusomedicamenta Sociedade Tecnica Farmaceutica S.A.
Responsible authority:
- Health Products Regulatory Authority
Authorisation number:
- VPA10988/116/001
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0431/001
Concerned member states:
-
Austria
-
Belgium
-
Czechia
-
Denmark
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Italy
-
Luxembourg
-
Netherlands
-
Norway
-
Portugal
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
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