Veterinary Medicine Information website

Amflee 2.5 mg/ml cutaneous spray, solution for cats and dogs

Authorised
  • Fipronil
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Product identification

Medicine name:
Amflee 2.5 mg/ml cutaneous spray, solution for cats and dogs
Active substance:
  • Fipronil
Target species:
  • Dog
  • Cat
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Fipronil
    2.50
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Cutaneous spray, 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:
  • Netherlands
Available in:
  • Netherlands
Package description:
  • (ID1) 100 millilitre(s): unspecified outer container with 1 Bottle (high-density polyethylene) with 100 millilitre(s)
  • (ID2) 250 millilitre(s): unspecified outer container with 1 Bottle (high-density polyethylene) with 250 millilitre(s)
  • (ID3) 500 millilitre(s): unspecified outer container with 1 Bottle (high-density polyethylene) with 500 millilitre(s)

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
  • TAD Pharma GmbH
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 114767
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0187/001
Concerned member states:
  • France
  • Greece
  • Italy
  • Netherlands
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 2/04/2026
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Summary of Product Characteristics

English (RTF)
Published on: 13/03/2026
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Package Leaflet

English (RTF)
Published on: 13/03/2026
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2402085-paren-20180308.rtf

English (RTF)
Published on: 13/03/2026
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