Veterinary Medicines

Tsefalen 50mg/ml Powder for Oral Suspension for Dogs up to 20kg and Cats

Authorised
  • Cefalexin
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Product identification

Medicine name:
Tsefalen 50mg/ml Powder for Oral Suspension for Dogs up to 20kg and Cats
Tsefalen, 50mg/ml, Prášek pro perorální suspenzi
Active substance:
  • Cefalexin
Target species:
  • Cat
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Cefalexin
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Powder for oral suspension
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01DB01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • Carton box with 1 bottle containing 40.0 g of powder providing 60 ml of suspension after reconstitution and 1 syringe of 5 ml
  • Carton box with 1 bottle containing 66.6 g of powder providing 100 ml of suspension after reconstitution and 1 syringe of 5 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Nextmune Italy S.r.l.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Acs Dobfar S.p.A.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/060/20-C
Date of authorisation status change:
Reference member state:
  • Italy
Procedure number:
  • IT/V/0142/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 8/03/2024
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Italian (PDF)
Published on: 3/03/2022
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Summary of Product Characteristics

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Czech (PDF)
Published on: 24/01/2025
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Package Leaflet

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Czech (PDF)
Published on: 24/01/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 24/01/2025
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