Veterinary Medicines

Tsefalen 1000 mg film-coated tablets for dogs

Authorised
  • Cefalexin
Download as PDF

Product identification

Medicine name:
Tsefalen 1000 mg comprimidos revestidos por película para cães
Tsefalen 1000 mg film-coated tablets for dogs
Active substance:
  • Cefalexin
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Cefalexin
    1000.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Film-coated tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01DB01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
Package description:
  • Carton box containing 13 PVC/Aluminium blister pack of 8 tablets, with a total of 104 tablets
  • Carton box containing 4 PVC/Aluminium blister pack of 8 tablets, with a total of 32 tablets
  • Carton box containing 1 PVC/Aluminium blister pack of 8 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:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 584/02/12DFVPT
Date of authorisation status change:
Reference member state:
  • Italy
Procedure number:
  • IT/V/0125/002
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: 15/02/2022
Download
Portuguese (PDF)
Published on: 30/12/2024
Download