Amflee 134 mg Spot-on Solution for Medium Dogs
Amflee 134 mg Spot-on Solution for Medium Dogs
Authorised
- Fipronil
Product identification
Medicine name:
Amflee 134 mg Spot-on Solution for Medium Dogs
Active substance:
- Fipronil
Target species:
-
Dog
Route of administration:
-
Cutaneous use
Product details
Active substance and strength:
-
Fipronil134.00/milligram(s)1.34millilitre(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:
-
United Kingdom (Northern Ireland)
Package description:
- (ID1) 1.34 millilitre(s): Box (cardboard) with 1 Pipette (polypropylene) with 1.34 millilitre(s)
- (ID2) 4.02 millilitre(s): Box (cardboard) with 3 Pipette (polypropylene) each with 1.34 millilitre(s)
- (ID3) 8.04 millilitre(s): Box (cardboard) with 6 Pipette (polypropylene) each with 1.34 millilitre(s)
- (ID4) 13.4 millilitre(s): Box (cardboard) with 10 Pipette (polypropylene) each with 1.34 millilitre(s)
- (ID5) 26.8 millilitre(s): Box (cardboard) with 20 Pipette (polypropylene) each with 1.34 millilitre(s)
- (ID6) 40.2 millilitre(s): Box (cardboard) with 30 Pipette (polypropylene) each with 1.34 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
- TAD Pharma GmbH
Responsible authority:
- The Veterinary Medicines Directorate
Authorisation number:
- Vm 01656/4088
Date of authorisation status change:
Reference member state:
-
Germany
Procedure number:
- DE/V/0191/003
Concerned member states:
-
France
-
Greece
-
Italy
-
Netherlands
-
Portugal
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
