Veterinary Medicines

DACLOTRIX 500 mg/100 mg spot-on solution for dogs over 4 kg up to 10 kg

Authorised
  • Permethrin (40:60)
  • Imidacloprid
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Product identification

Medicine name:
DACLOTRIX 500 mg/100 mg spot-on solution for dogs over 4 kg up to 10 kg
DACLOTRIX 500 mg/100 mg SOLUCION PARA UNCION DORSAL PUNTUAL PARA PERROS DE MAS DE 4 KG HASTA 10 KG
Active substance:
  • Permethrin (40:60)
  • Imidacloprid
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • Permethrin (40:60)
    500.00
    milligram(s)
    /
    1.00
    Pipette
  • Imidacloprid
    100.00
    milligram(s)
    /
    1.00
    Pipette
Pharmaceutical form:
  • Spot-on solution
Withdrawal period by route of administration:
  • Spot-on use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AC54
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available 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:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 4068 ESP
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0774/002
Concerned member states:
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 6/07/2025
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Spanish (PDF)
Published on: 8/09/2025
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Combined File of all Documents

English (PDF)
Published on: 6/07/2025
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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: 8/09/2025
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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: 8/09/2025
Download
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