Fyperix 402 mg spot-on solution for dogs
Fyperix 402 mg spot-on solution for dogs
Authorised
- Fipronil
Product identification
Medicine name:
Fyperix 402 mg spot-on solution for dogs
FYPERIX 402 MG SOLUTION SPOT-ON POUR CHIENS
Active substance:
- Fipronil
Target species:
-
Dog
Route of administration:
-
Cutaneous use
Product details
Active substance and strength:
-
Fipronil402.00/milligram(s)4.02millilitre(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:
-
France
Available in:
-
France
Package description:
- (ID6) 120.6 millilitre(s): Box (board) with 30 Beutel (low-density polyethylene; polyethylene terephthalate; aluminium) each with 1 Pipette (polypropylene) with 4.02 millilitre(s)
- (ID5) 80.4 millilitre(s): Box (board) with 20 Beutel (low-density polyethylene; polyethylene terephthalate; aluminium) each with 1 Pipette (polypropylene) with 4.02 millilitre(s)
- (ID4) 40.2 millilitre(s): Box (board) with 10 Beutel (low-density polyethylene; polyethylene terephthalate; aluminium) each with 1 Pipette (polypropylene) with 4.02 millilitre(s)
- (ID3) 24.12 millilitre(s): Box (board) with 6 Beutel (low-density polyethylene; polyethylene terephthalate; aluminium) each with 1 Pipette (polypropylene) with 4.02 millilitre(s)
- (ID2) 12.06 millilitre(s): Box (board) with 3 Beutel (low-density polyethylene; polyethylene terephthalate; aluminium) each with 1 Pipette (polypropylene) with 4.02 millilitre(s)
- (ID1) 4.02 millilitre(s): Box (board) with Beutel (low-density polyethylene; polyethylene terephthalate; aluminium) with 1 Pipette (polypropylene) with 4.02 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:
- French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
- FR/V/3128734 8/2012
Date of authorisation status change:
Reference member state:
-
Germany
Procedure number:
- DE/V/0190/005
Concerned member states:
-
Finland
-
France
-
Italy
-
Portugal
-
Spain
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
