Authorised

Product identification

Medicine name:
DACLOTRIX 200 mg/40 mg spot-on solution for dogs up to 4 kg
DACLOTRIX 200 mg/40 mg spot-on solution for dogs up to 4 kg
Active substance:
  • Permethrin (Cis:Trans 40:60)
  • Imidacloprid
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • Permethrin (Cis:Trans 40:60)
    200.00
    milligram(s)
    /
    1.00
    Pipette
  • Imidacloprid
    40.00
    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 subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • White polypropylene pipette closed with a polyethylene (HDPE) cap. Each pipette is packed in a polyethylene terephthalate/aluminium/low density polyethylene triplex bag. 1 ml pipette containing 0.4 ml of solution Box containing 10 pipettes
  • White polypropylene pipette closed with a polyethylene (HDPE) cap. Each pipette is packed in a polyethylene terephthalate/aluminium/low density polyethylene triplex bag. 1 ml pipette containing 0.4 ml of solution Box containing 6 pipettes
  • White polypropylene pipette closed with a polyethylene (HDPE) cap. Each pipette is packed in a polyethylene terephthalate/aluminium/low density polyethylene triplex bag. 1 ml pipette containing 0.4 ml of solution Box containing 4 pipettes
  • White polypropylene pipette closed with a polyethylene (HDPE) cap. Each pipette is packed in a polyethylene terephthalate/aluminium/low density polyethylene triplex bag. 1 ml pipette containing 0.4 ml of solution Box containing 3 pipettes
  • White polypropylene pipette closed with a polyethylene (HDPE) cap. Each pipette is packed in a polyethylene terephthalate/aluminium/low density polyethylene triplex bag. 1 ml pipette containing 0.4 ml of solution Box containing 1 pipette

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
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10774/074/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0774/001
Concerned member states:
  • Spain
Source URL: https://medicines.health.europa.eu/veterinary/600000093221