Veterinary Medicines

PROTECTIX 100 MG/500 MG SPOT-ON SOLUTION FOR DOGS OVER 4 KG UP TO 10 KG

Authorised
  • Imidacloprid
  • Permethrin
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Product identification

Medicine name:
PROTECTIX 100 MG/500 MG SPOT-ON SOLUTION FOR DOGS OVER 4 KG UP TO 10 KG
ProtecTix 100 mg/500 mg kožni nanos, raztopina za pse nad 4 kg do 10 kg
Active substance:
  • Imidacloprid
  • Permethrin
Target species:
  • Dog
Route of administration:
  • Cutaneous 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:
  • Cutaneous 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:
  • Slovenia
Package description:
  • Pack containing 1 PET/PE/aluminium/surlyn sachet containing one white polypropylene unit dose pipette
  • Pack containing 2 PET/PE/aluminium/surlyn sachets each containing one white polypropylene unit dose pipette
  • Pack containing 3 PET/PE/aluminium/surlyn sachets each containing one white polypropylene unit dose pipette
  • Pack containing 4 PET/PE/aluminium/surlyn sachets each containing one white polypropylene unit dose pipette
  • Pack containing 6 PET/PE/aluminium/surlyn sachets each containing one white polypropylene unit dose pipette
  • Pack containing 12 PET/PE/aluminium/surlyn sachets each containing one white polypropylene unit dose pipette
  • Pack containing 24 PET/PE/aluminium/surlyn sachets each containing one white polypropylene unit dose 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:
  • Beaphar B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Beaphar B.V.
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • DC/V/0801/002
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0433/002
Concerned member states:
  • Croatia
  • Cyprus
  • Czechia
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Malta
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 15/02/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 15/02/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 15/02/2024
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