Veterinary Medicines

DUOFLECT SPOT-ON SOLUTION FOR DOGS 2-10 KG AND CATS > 5KG

Authorised
  • Fipronil
  • Methoprene
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Product identification

Medicine name:
DUOFLECT SPOT-ON SOLUTION FOR DOGS 2-10 KG AND CATS > 5KG
DUOFLECT soluție spot-on pentru câini 2-10 kg și pisici > 5kg
Active substance:
  • Fipronil
  • Methoprene
Target species:
  • Dog
  • Cat
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Fipronil
    120.70
    milligram(s)
    /
    1.00
    Pipette
  • Methoprene
    60.35
    milligram(s)
    /
    1.00
    Pipette
Pharmaceutical form:
  • Spot-on solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AX65
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:
  • Pack containing 1 pipette
  • Pack containing 120 pipettes
  • Pack containing 60 pipettes
  • Pack containing 24 pipettes
  • Pack containing 12 pipettes
  • Pack containing 6 pipettes
  • Pack containing 3 pipettes

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva Sante Animale Romania S.R.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
  • Klocke Verwaltungs GmbH
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 240146
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0345/002
Concerned member states:
  • Belgium
  • Croatia
  • Germany
  • Italy
  • Luxembourg
  • Romania
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Romanian (PDF)
Published on: 12/11/2024
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