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CEVAXEL-RTU 50 MG/ML, SUSPENSION FOR INJECTION FOR CATTLE AND PIGS

Authorised
  • Ceftiofur hydrochloride
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Product identification

Medicine name:
CEVAXEL-RTU 50 MG/ML, SUSPENSION FOR INJECTION FOR CATTLE AND PIGS
Active substance:
  • Ceftiofur hydrochloride
Target species:
  • Pig
  • Cattle
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Ceftiofur hydrochloride
    53.45
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        5
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        8
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01DD90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • Cardboard box containing one 100 ml vial
  • Cardboard box containing one 50 ml vial
  • Cardboard box containing one 250 ml vial

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:
  • Ceva Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V387134
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0218/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • 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.
French (PDF)
Published on: 18/08/2025
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Dutch (PDF)
Published on: 18/08/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Dutch (PDF)
Published on: 18/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Dutch (PDF)
Published on: 18/08/2025
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Combined File of all Documents

English (PDF)
Published on: 14/03/2026
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