Veterinary Medicines Information website

Amflee 402 mg Spot-on Solution for Extra Large Dogs

Authorised
  • Fipronil
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Product identification

Medicine name:
Amflee 402 mg Spot-on Solution for Extra Large Dogs
Active substance:
  • Fipronil
Target species:
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Fipronil
    402.00
    milligram(s)
    /
    4.02
    millilitre(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) 4.02 millilitre(s): Box (cardboard) with Beutel (low-density polyethylene; polyethylene terephthalate; aluminium) with 1 Pipette (polypropylene) with 4.02 millilitre(s)
  • (ID2) 12.06 millilitre(s): Box (cardboard) with 3 Beutel (low-density polyethylene; polyethylene terephthalate; aluminium) each with 1 Pipette (polypropylene) with 4.02 millilitre(s)
  • (ID3) 24.12 millilitre(s): Box (cardboard) with 6 Beutel (low-density polyethylene; polyethylene terephthalate; aluminium) each with 1 Pipette (polypropylene) with 4.02 millilitre(s)
  • (ID4) 40.2 millilitre(s): Box (cardboard) with 10 Beutel (low-density polyethylene; polyethylene terephthalate; aluminium) each with 1 Pipette (polypropylene) with 4.02 millilitre(s)
  • (ID5) 80.4 millilitre(s): Box (cardboard) with 20 Beutel (low-density polyethylene; polyethylene terephthalate; aluminium) each with 1 Pipette (polypropylene) with 4.02 millilitre(s)
  • (ID6) 120.6 millilitre(s): Box (cardboard) with 30 Beutel (low-density polyethylene; polyethylene terephthalate; aluminium) each 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
  • TAD Pharma GmbH
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • Vm 01656/4090
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0191/005
Concerned member states:
  • France
  • Greece
  • Italy
  • Netherlands
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 24/03/2026
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2402111-paren-20180308.rtf

English (RTF)
Published on: 14/03/2026
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