Veterinary Medicines

DV8FLEA COMBO XL 402 mg / 361.8 mg spot-on solution for dogs

Authorised
  • (S)-Methoprene
  • Fipronil
Download as PDF

Product identification

Medicine name:
DV8FLEA COMBO XL 402 mg / 361.8 mg spot-on solution for dogs
Active substance:
  • (S)-Methoprene
  • Fipronil
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • (S)-Methoprene
    361.80
    milligram(s)
    /
    1.00
    Pipette
  • Fipronil
    402.00
    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:
  • Ireland
Package description:
  • A red pipette composed of a heat-formed shell ( internal layer PE/EVOH/PE external layer PP/COC/PP) and a film (PET/PE/ALU/PE). Package sizes: 1 x 4.02 ml pipette in carton box

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Duggan Veterinary Supplies Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Przedsiebiorstwo Wielobranzowe Vet-Agro Sp. z o.o.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10400/005/004
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download