Veterinary Medicines

Tsefalen 500 mg film-coated tablets for dogs

Authorised
  • Cefalexin
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Product identification

Medicine name:
Tsefalen 500 mg film-coated tablets for dogs
TSEFALEN 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA PARA PERROS
Active substance:
  • Cefalexin
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Cefalexin
    500.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Film-coated tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01DB01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • Carton box containing 9 PVC/Aluminium blister pack of 12 tablets, with a total of 108 tablets
  • Carton box containing 3 PVC/Aluminium blister pack of 12 tablets, with a total of 36 tablets
  • Carton box containing 1 PVC/Aluminium blister pack of 12 tablets

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:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 2633 ESP
Date of authorisation status change:
Reference member state:
  • Italy
Procedure number:
  • IT/V/0125/001
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

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 19/12/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 19/12/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 19/12/2024
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