Veterinary Medicines

Flevox 134 mg spot-on solution for medium dogs

Authorised
  • Fipronil
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Product identification

Medicine name:
FLEVOX 134 mg SOLUCION PARA UNCIÓN DORSAL PUNTUAL PARA PERROS MEDIANOS
Flevox 134 mg spot-on solution for medium dogs
Active substance:
  • Fipronil
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • Fipronil
    134.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Spot-on solution
Withdrawal period by route of administration:
  • Spot-on use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AX15
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:

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:
  • Vetoquinol Especialidades Veterinarias S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetoquinol S.A.
  • Vetoquinol Biowet Sp. z o.o.
Responsible authority:
  • Spanish Agency For Medicines And Health Products
Authorisation number:
  • 2306 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0355/003
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 23/03/2023
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Spanish (PDF)
Published on: 17/03/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 17/03/2023
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 17/03/2023
Download
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