Veterinary Medicines

Cestem flavoured tablets for medium and small dogs

Not authorised
  • Pyrantel embonate
  • Praziquantel
  • Febantel
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Product identification

Medicine name:
Cestem flavoured tablets for medium and small dogs
CESTEM Flavoured tablety pre stredne veľké a malé psy
Active substance:
  • Pyrantel embonate
  • Praziquantel
  • Febantel
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Pyrantel embonate
    50.00
    milligram(s)
    /
    1.00
    Piece
  • Praziquantel
    50.00
    milligram(s)
    /
    1.00
    Piece
  • Febantel
    150.00
    milligram(s)
    /
    1.00
    Piece
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 not subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Slovakia
Package description:
  • Polyamide-aluminium-PVC / aluminium blister packs.Box containing 1 blister of 8 tablets.
  • Polyamide-aluminium-PVC / aluminium blister packs. Box containing 2 blisters of 2 tablets.
  • Polyamide-aluminium-PVC / aluminium blister packs. Box containing 13 blisters of 8 tablets.
  • Polyamide-aluminium-PVC / aluminium blister packs. Box containing 1 blister of 2 tablets.
  • Polyamide-aluminium-PVC / aluminium blister packs.Box containing 52 blisters 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 Animal Health Slovakia s.r.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
  • Ceva Sante Animale
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/028/MR/10-S
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0269/001

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Slovak (PDF)
Published on: 2/02/2022
Download

Package Leaflet and Labelling

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

PuAR Cestem - 20230619.pdf

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