Veterinary Medicines

SIMBIA 4.50 G + 2.03 G MEDICATED COLLAR FOR DOGS OVER 8 KG

Authorised
  • Imidacloprid
  • Flumethrin
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Product identification

Medicine name:
SIMBIA 4.50 G + 2.03 G MEDICATED COLLAR FOR DOGS OVER 8 KG
SIMBIA 4,50 g + 2,03 g COLLAR MEDICAMENTOSO PARA PERROS DE MAS DE 8 KG
Active substance:
  • Imidacloprid
  • Flumethrin
Target species:
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Imidacloprid
    4.50
    gram(s)
    /
    1.00
    Collar
  • Flumethrin
    2.03
    gram(s)
    /
    1.00
    Collar
Pharmaceutical form:
  • Medicated collar
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AC55
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • Outer box containing 1 collar individually packed in a PET/PE/aluminium/surlyn sachet
  • Outer box containing 2 collars individually packed in a PET/PE/aluminium/surlyn sachet
  • Outer box containing 12 collars individually packed in a PET/PE/aluminium/surlyn sachet

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application - change in active substance(s) (Article 19(1)(a) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Beaphar B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Beaphar B.V.
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 4485 ESP
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0512/003
Concerned member states:
  • Czechia
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovenia
  • Spain

Documents

Summary of Product Characteristics

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Spanish (PDF)
Published on: 29/01/2026
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Package Leaflet

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Spanish (PDF)
Published on: 29/01/2026
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 29/01/2026
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