Veterinary Medicines

SEMELCEF 200 mg tablets for dogs and cats

Authorised
  • Cefadroxil monohydrate
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Product identification

Medicine name:
SEMELCEF 200 mg tablets for dogs and cats
Semelcef 200 mg Tablet
Semelcef 200 mg Comprimé
Semelcef 200 mg Tablette
Active substance:
  • Cefadroxil monohydrate
Target species:
  • Dog
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Cefadroxil monohydrate
    210.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01DB05
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Available in:
  • Belgium
Package description:
  • box containing 10 blisters of 10 tablets (100 tablets)
  • box containing 1 blister of 10 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:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V545306
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0304/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Cyprus
  • Czechia
  • Estonia
  • Greece
  • Hungary
  • Ireland
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

English (PDF)
Published on: 25/12/2023
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Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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German (PDF)
Published on: 22/03/2022
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Summary of Product Characteristics

English (PDF)
Published on: 25/12/2023
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Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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Labelling

English (PDF)
Published on: 25/12/2023
Download

eu-PUAR-esv0304001-dcp-semelcef-200-mg-tablets-for-dogs-and-cats-en.pdf

English (PDF)
Published on: 25/12/2023
Download
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