Veterinary Medicines

Cepebiotic 330 mg/100 mg intramammary solution for cattle

Authorised
  • NEOMYCIN SULFATE
  • Lincomycin hydrochloride
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Product identification

Medicine name:
Cepebiotic 330 mg/100 mg intramammary solution for cattle
Cepebiotic 330 mg/100 mg Lösung zur intramammären Anwendung für Rinder
Active substance:
  • NEOMYCIN SULFATE
  • Lincomycin hydrochloride
Target species:
  • Cattle
Route of administration:
  • Intramammary use

Product details

Active substance and strength:
  • NEOMYCIN SULFATE
    144.00
    milligram(s)
    /
    1.00
    Syringe
  • Lincomycin hydrochloride
    376.00
    milligram(s)
    /
    1.00
    Syringe
Pharmaceutical form:
  • Intramammary solution
Withdrawal period by route of administration:
  • Intramammary use
    • Cattle
      • Meat and offal
        3
        day
      • Milk
        84
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ51RF03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Austria
Package description:
  • Cardboard box with 4 LLDPE injectors with 10 ml solution each
  • Cardboard box with 12 LLDPE injectors with 10 ml solution each
  • Cardboard box with 24 LLDPE injectors with 10 ml solution each
  • Cardboard box with 48 LLDPE injectors with 10 ml solution each
  • Cardboard box with 144 LLDPE injectors with 10 ml solution each

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • CP-Pharma Handelsgesellschaft mbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • CP-Pharma Handelsgesellschaft mbH
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 842824
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0421/001
Concerned member states:
  • Austria
  • Belgium
  • Germany
  • Hungary
  • Spain

Documents

Combined File of all Documents

English (PDF)
Published on: 28/07/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 30/07/2025
Updated on: 31/07/2025
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 30/07/2025
Updated on: 31/07/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 30/07/2025
Updated on: 31/07/2025
Download
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