Veterinary Medicines

EFFINOL

Authorised
  • Fipronil
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Product identification

Medicine name:
EFFINOL, 2.5 mg/ml cutaneous spray, solution for cats and dogs
EFFINOL
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
Withdrawal period by route of administration:
  • Cutaneous use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AX15
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Greece
Package description:
  • bottle of 500 ml
  • bottle of 250 ml
  • bottle of 100 ml

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:
  • Laboratorios Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Calier S.A.
Responsible authority:
  • National Organization For Medicines
Authorisation number:
  • 65860/30-06-2020/K-0216006
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0214/001
Concerned member states:
  • Bulgaria
  • Estonia
  • Germany
  • Greece
  • Italy
  • Latvia
  • Portugal

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2023
Download
Greek (PDF)
Published on: 10/05/2022
Download

Package Leaflet

English (PDF)
Published on: 22/12/2023
Download

Labelling

English (PDF)
Published on: 22/12/2023
Download

eu-PUAR-esv0214001-dcp-effinol--2.5-mg-ml-cutaneous-spray--solution-for-cats-and-dogs-en.pdf

English (PDF)
Published on: 22/12/2023
Download
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