Veterinary Medicines

SEMELCEF 1000 mg tablets for dogs

Authorised
  • Cefadroxil monohydrate
Download as PDF

Product identification

Medicine name:
SEMELCEF 1000 mg tablets for dogs
SEMELCEF, 1000 mg, tableta, za pse
Active substance:
  • Cefadroxil monohydrate
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Cefadroxil monohydrate
    1050.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01DB05
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Croatia
Available in:
  • Croatia
Package description:
  • box containing 10 blisters of 6 tablets (60 tablets)
  • box containing 1 blister of 6 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:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/19-01/415
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0304/002
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Cyprus
  • Czechia
  • Estonia
  • Greece
  • Hungary
  • Ireland
  • Poland
  • Portugal
  • Slovakia
  • Slovenia

Documents

Summary of Product Characteristics

English (PDF)
Published on: 29/01/2026
Download
Croatian (PDF)
Published on: 4/04/2022
Download

Labelling

English (PDF)
Published on: 22/12/2023
Download

Package Leaflet

English (PDF)
Published on: 29/01/2026
Download

eu-PUAR-esv0304002-dcp-semelcef-1000-mg-tablets-for-dogs-en.pdf

English (PDF)
Published on: 22/12/2023
Download