Veterinary Medicines

FIPRODOG 402 mg Spot-on solution for very large dogs

Authorised
  • Fipronil
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Product identification

Medicine name:
FIPRODOG 402 mg Spot-on solution for very large dogs
Fiprodog 402 mg spot-on oplossing voor zeer grote honden
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:
  • Netherlands
Package description:
  • (ID6) 482.4 millilitre(s): unspecified outer container with 120 Pipette each with 4.02 millilitre(s)
  • (ID5) 241.2 millilitre(s): unspecified outer container with 60 Pipette each with 4.02 millilitre(s)
  • (ID4) 96.48 millilitre(s): unspecified outer container with 24 Pipette each with 4.02 millilitre(s)
  • (ID3) 48.24 millilitre(s): unspecified outer container with 12 Pipette each with 4.02 millilitre(s)
  • (ID2) 24.12 millilitre(s): unspecified outer container with 6 Pipette each with 4.02 millilitre(s)
  • (ID1) 12.06 millilitre(s): unspecified outer container with 3 Pipette each 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:
  • Domes Pharma
Marketing authorisation date:
Manufacturing sites for batch release:
  • Klocke Verpackungs-Service GmbH
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 106396
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0138/005
Concerned member states:
  • Cyprus
  • France
  • Greece
  • Luxembourg
  • Netherlands
  • Romania

Documents

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Dutch (PDF)
Published on: 19/05/2025
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