Veterinary Medicines

Orbenin extra dry cow 600 mg suspensie voor intramammair gebruik voor runderen

Authorised
  • Cloxacillin hemibenzathine
Download as PDF

Product identification

Medicine name:
Orbenin extra dry cow 600 mg suspensie voor intramammair gebruik voor runderen
Active substance:
  • Cloxacillin hemibenzathine
Target species:
  • Cattle
Route of administration:
  • Intramammary use

Product details

Active substance and strength:
  • Cloxacillin hemibenzathine
    600.00
    milligram(s)
    /
    1.00
    Syringe
Pharmaceutical form:
  • Intramammary suspension
Withdrawal period by route of administration:
  • Intramammary use
    • Cattle
      • Milk
        44
        day
      • Milk
        48
        hour
      • Meat and offal
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ51CF02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
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 B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Haupt Pharma Latina S.r.l.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 6901
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.
Dutch (PDF)
Published on: 22/05/2024
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."