Veterinary Medicines

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

Authorised
  • Imidacloprid
  • Permethrin
Download as PDF

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 voor honden met een gewicht van 4 kg tot 10 kg
Active substance:
  • Imidacloprid
  • Permethrin
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • Imidacloprid
    100.00
    milligram(s)
    /
    1.00
    Pipette
  • Permethrin
    500.00
    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:
  • Netherlands
Package description:
  • White polypropylene pipette closed with either a polyethylene or polyoxymethylene cap. Each pipette is packed in apolyethylene 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 apolyethylene 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 apolyethylene 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 apolyethylene 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 apolyethylene 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:
  • Krka d.d. Novo Mesto
  • Tad Pharma GmbH
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 115887
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

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 15/08/2023
Updated on: 16/08/2023
Download

Summary of Product Characteristics

English (PDF)
Published on: 28/01/2022
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."