Veterinary Medicines

Amflee Combo 134 mg/ 120.6 mg spot-on solution for medium dogs

Authorised
  • Fipronil
  • (S)-Methoprene
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Product identification

Medicine name:
Amflee Combo 134 mg/ 120.6 mg spot-on solution for medium dogs
Amflee Combo 134 mg/120,6 mg Lösung zum Auftropfen für mittelgroße Hunde
Active substance:
  • Fipronil
  • (S)-Methoprene
Target species:
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Fipronil
    134.00
    milligram(s)
    /
    1.34
    millilitre(s)
  • (S)-Methoprene
    120.60
    milligram(s)
    /
    1.34
    millilitre(s)
Pharmaceutical form:
  • Spot-on solution
Withdrawal period by route of administration:
  • Cutaneous use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AX65
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Available in:
  • Germany
Package description:
  • (ID3) 8.04 millilitre(s): unspecified outer container with 6 Pipette (PolyPropylene) each with 1.34 millilitre(s)
  • (ID2) 4.02 millilitre(s): unspecified outer container with 3 Pipette (PolyPropylene) each with 1.34 millilitre(s)
  • (ID1) 1.34 millilitre(s): unspecified outer container with 1 Pipette (PolyPropylene) with 1.34 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:
  • TAD Pharma GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 402388.00.00
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0185/003
Concerned member states:
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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German (PDF)
Published on: 29/07/2025
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2402388-paren-20180531.rtf

English (RTF)
Published on: 18/12/2024
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