Veterinary Medicines

Orbenin DC 500 mg intramamálna suspenzia

Authorised
  • Cloxacillin hemibenzathine
Download as PDF

Product identification

Medicine name:
Orbenin DC 500 mg intramamálna suspenzia
Active substance:
  • Cloxacillin hemibenzathine
Target species:
  • Cattle (dairy cow at drying-off)
Route of administration:
  • Intramammary use

Product details

Active substance and strength:
  • Cloxacillin hemibenzathine
    1275.60
    milligram(s)
    /
    1.00
    Syringe
Pharmaceutical form:
  • Intramammary suspension
Withdrawal period by route of administration:
  • Intramammary use
    • Cattle (dairy cow at drying-off)
      • Meat and offal
        28
        day
      • Milk
        96
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ51CF02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
Available in:
  • Slovakia
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
  • Zoetis Ceska Republika s.r.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Haupt Pharma Latina S.r.l.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/256/91-S
Date of authorisation status change:

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Slovak (PDF)
Published on: 19/03/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."