Veterinary Medicines

PROTEL XL COMPRIMES POUR GRANDS CHIENS

Authorised
  • Febantel
  • Praziquantel
  • Pyrantel embonate
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Product identification

Medicine name:
PROTEL XL COMPRIMES POUR GRANDS CHIENS
Active substance:
  • Febantel
  • Praziquantel
  • Pyrantel embonate
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Febantel
    525.00
    milligram(s)
    /
    1.00
    Tablet
  • Praziquantel
    175.00
    milligram(s)
    /
    1.00
    Tablet
  • Pyrantel embonate
    504.44
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52AA51
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription except for some pack sizes
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:

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:
  • Ceva Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
  • Ceva Sante Animale
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/8985613 0/2025
Date of authorisation status change:

Documents

Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 10/10/2025
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 10/10/2025
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fr-puar-700000192005-np-rpe942-fr.pdf

French (PDF)
Published on: 7/01/2026
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