Authorised

Product identification

Medicine name:
Ataxxa 500 mg/100 mg spot-on solution for dogs over 4 kg up to 10 kg
Ataxxa 500 mg - 100 mg Spot-on oplossing
Ataxxa 500 mg - 100 mg Solution pour spot-on
Ataxxa 500 mg - 100 mg Lösung zum Auftropfen
Active substance:
  • Permethrin
  • Imidacloprid
Target species:
  • Dog
Route of administration:
  • Topical use

Product details

Active substance and strength:
  • Permethrin
    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:
  • Topical use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AC54
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • White polypropylene pipette closed with either a polyethylene or polyoxymethylene cap. Each pipette is packed in a polyethylene terephthalate/aluminium/low density polyethylene triplex bag. 3 ml pipette containing 1 ml of solution. Box containing 10 pipettes.
  • White polypropylene pipette closed with either a polyethylene or polyoxymethylene cap. Each pipette is packed in a polyethylene terephthalate/aluminium/low density polyethylene triplex bag. 3 ml pipette containing 1 ml of solution. Box containing 6 pipettes.
  • White polypropylene pipette closed with either a polyethylene or polyoxymethylene cap. Each pipette is packed in a polyethylene terephthalate/aluminium/low density polyethylene triplex bag. 3 ml pipette containing 1 ml of solution. Box containing 4 pipettes.
  • White polypropylene pipette closed with either a polyethylene or polyoxymethylene cap. Each pipette is packed in a polyethylene terephthalate/aluminium/low density polyethylene triplex bag. 3 ml pipette containing 1 ml of solution. Box containing 3 pipettes.
  • White polypropylene pipette closed with either a polyethylene or polyoxymethylene cap. Each pipette is packed in a polyethylene terephthalate/aluminium/low density polyethylene triplex bag. 3 ml pipette containing 1 ml of solution. Box containing 1 pipettes.

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:
  • Tad Pharma GmbH
  • Krka d.d. Novo Mesto
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V490986
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0439/002
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Estonia
  • France
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 28/01/2022
Download
Dutch (PDF)
Published on: 22/03/2023
Download
French (PDF)
Published on: 22/03/2023
Download
German (PDF)
Published on: 22/03/2023
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2023
Download
French (PDF)
Published on: 22/03/2023
Download
German (PDF)
Published on: 22/03/2023
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000046779