Fyperix 50 mg spot-on solution for cats
Fyperix 50 mg spot-on solution for cats
Authorised
- Fipronil
Product identification
Medicine name:
Fyperix 50 mg spot-on solution for cats
FYPERIX 50 mg SOLUCION PARA UNCION DORSAL PUNTUAL PARA GATOS
Active substance:
- Fipronil
Target species:
-
Cat
Route of administration:
-
Cutaneous use
Product details
Active substance and strength:
-
Fipronil50.00/milligram(s)0.50millilitre(s)
Pharmaceutical form:
-
Spot-on solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QP53AX15
Legal status of supply:
-
Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Spain
Package description:
- (ID6) 15 millilitre(s): Box (board) with 30 Beutel (polyethylene terephthalate; aluminium; low-density polyethylene) each with 1 Pipette (polypropylene) with 0.5 millilitre(s)
- (ID5) 10 millilitre(s): Box (board) with 20 Beutel (polyethylene terephthalate; aluminium; low-density polyethylene) each with 1 Pipette (polypropylene) with 0.5 millilitre(s)
- (ID4) 5 millilitre(s): Box (board) with 10 Beutel (polyethylene terephthalate; aluminium; low-density polyethylene) each with 1 Pipette (polypropylene) with 0.5 millilitre(s)
- (ID3) 3 millilitre(s): Box (board) with 6 Beutel (polyethylene terephthalate; aluminium; low-density polyethylene) each with 1 Pipette (polypropylene) with 0.5 millilitre(s)
- (ID2) 1.5 millilitre(s): Box (board) with 3 Beutel (polyethylene terephthalate; aluminium; low-density polyethylene) each with 1 Pipette (polypropylene) with 0.5 millilitre(s)
- (ID1) 0.5 millilitre(s): Box (board) with Beutel (polyethylene terephthalate; aluminium; low-density polyethylene) with 1 Pipette (polypropylene) with 0.5 millilitre(s)
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
- KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
- Spanish Agency Of Medicines And Medical Devices
Authorisation number:
- 2594 ESP
Date of authorisation status change:
Reference member state:
-
Germany
Procedure number:
- DE/V/0190/001
Concerned member states:
-
Finland
-
France
-
Italy
-
Portugal
-
Spain
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet