Veterinary Medicines

Cestem flavoured tablets for large dogs

Authorised
  • Pyrantel embonate
  • Febantel
  • Praziquantel
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Product identification

Medicine name:
Cestem flavoured tablets for large dogs
Cestem Tabletten mit Geschmack für große Hunde
Active substance:
  • Pyrantel embonate
  • Febantel
  • Praziquantel
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Pyrantel embonate
    175.00
    milligram(s)
    /
    1.00
    Tablet
  • Febantel
    525.00
    milligram(s)
    /
    1.00
    Tablet
  • Praziquantel
    175.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52AA51
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Package description:
  • Polyamide-aluminium-PVC / aluminium blister packs. Box containing 24 blister of 2 tablets.
  • Polyamide-aluminium-PVC / aluminium blister packs. Box containing 12 blister of 4 tablets.
  • Polyamide-aluminium-PVC / aluminium blister packs. Box containing 1 blister of 2 tablets.
  • Polyamide-aluminium-PVC / aluminium blister packs. Box containing 2 blister of 4 tablets.
  • Polyamide-aluminium-PVC / aluminium blister packs. Box containing 2 blister of 2 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 Tiergesundheit GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
  • CEVA Santé Animale
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 401385.01.00
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0269/002
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

Package Leaflet and Labelling

English (PDF)
Published on: 5/03/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 13/01/2025
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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.
German (PDF)
Published on: 13/01/2025
Download

PuAR Cestem - 20230619.pdf

English (PDF)
Published on: 5/03/2024
Download
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