Amflee Combo 402 mg/361.8 mg spot-on solution for extra large dogs
Amflee Combo 402 mg/361.8 mg spot-on solution for extra large dogs
Authorised
- (S)-Methoprene
- Fipronil
Product identification
Medicine name:
Amflee Combo 402 mg/361.8 mg spot-on solution for extra large dogs
Fleascreen Combo 402 mg - 361.8 mg Spot-on oplossing
Fleascreen Combo 402 mg - 361.8 mg Solution pour spot-on
Fleascreen Combo 402 mg - 361.8 mg Lösung zum Auftropfen
Active substance:
- (S)-Methoprene
- Fipronil
Target species:
-
Dog
Route of administration:
-
Spot-on use
Product details
Active substance and strength:
-
(S)-Methoprene361.80/milligram(s)1.00Pipette
-
Fipronil402.00/milligram(s)1.00Pipette
Pharmaceutical form:
-
Spot-on solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QP53AX65
Legal status of supply:
-
Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Available in:
-
Belgium
Package description:
- White polypropylene single-dose pipette packaged in aluminium foil sachets.Cardboard box containing 1 pipette.
- White polypropylene single-dose pipette packaged in aluminium foil sachets.Cardboard box containing 3 pipettes.
- White polypropylene single-dose pipette packaged in aluminium foil sachets.Cardboard box containing 6 pipettes.
- White polypropylene single-dose pipette packaged in aluminium foil sachets.Cardboard box containing 30 pipettes.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) 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:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V536773
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0451/005
Concerned member states:
-
Belgium
-
Cyprus
-
Finland
-
Italy
-
Portugal
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
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Combined File of all Documents
English (PDF)
Download Published on: 19/01/2025
Labelling
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