Veterinary Medicines Information website

Cestem flavoured tablets for medium and small dogs

Authorised
  • Febantel
  • Praziquantel
  • Pyrantel embonate
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Product identification

Medicine name:
Cestem flavoured tablets for medium and small dogs
Active substance:
  • Febantel
  • Praziquantel
  • Pyrantel embonate
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Febantel
    150.00
    milligram(s)
    /
    1.00
    Tablet
  • Praziquantel
    50.00
    milligram(s)
    /
    1.00
    Tablet
  • Pyrantel embonate
    50.00
    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
Authorisation status:
  • Valid
Authorised in:
  • Greece
Available in:
  • Greece
Package description:
  • Polyamide-aluminium-PVC / aluminium blister packs. Box containing 52 blisters of 2 tablets.
  • Polyamide-aluminium-PVC / aluminium blister packs. Box containing 1 blister of 2 tablets.
  • Polyamide-aluminium-PVC / aluminium blister packs. Box containing 13 blisters of 8 tablets.
  • Polyamide-aluminium-PVC / aluminium blister packs. Box containing 2 blisters of 2 tablets.
  • Polyamide-aluminium-PVC / aluminium blister packs. Box containing 1 blister of 8 tablets.

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:
  • Ceva Hellas LLC
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
  • Ceva Sante Animale
Responsible authority:
  • National Organization For Medicines
Authorisation number:
  • 6373/29-01-2016/K-0187901
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0269/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 9/09/2026
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Package Leaflet

English (PDF)
Published on: 9/09/2026
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Combined File of all Documents

English (PDF)
Published on: 17/12/2025
Updated on: 14/03/2026
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PuAR Cestem - 20230619.pdf

English (PDF)
Published on: 5/03/2024
Updated on: 14/03/2026
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106871 PAR.pdf

English (PDF)
Published on: 14/06/2022
Updated on: 13/03/2026
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