Veterinary Medicines

Orbenin Dry Cow 500 mg Intramammary Suspension

Authorised
  • Cloxacillin hemibenzathine
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Product identification

Medicine name:
Orbenin Dry Cow 500 mg Intramammary Suspension
Active substance:
  • Cloxacillin hemibenzathine
Target species:
  • Cattle
Route of administration:
  • Intramammary use

Product details

Active substance and strength:
  • Cloxacillin hemibenzathine
    1275.64
    milligram(s)
    /
    1.00
    Syringe
Pharmaceutical form:
  • Intramammary suspension
Withdrawal period by route of administration:
  • Intramammary use
    • Cattle
      • Meat and offal
        28
        day
      • Milk
        39
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ51CF02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • White low density polyethylene intramammary syringe barrel containing 3 g of suspension with plunger. The closure is a white low density polyethylene push-fit combined dual nozzle and cap. Pack containing 24 syringes.
  • White low density polyethylene intramammary syringe barrel containing 3 g of suspension with plunger. The closure is a white low density polyethylene push-fit combined dual nozzle and cap. Pack containing 120 syringes.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Zoetis Belgium S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Haupt Pharma Latina S.r.l.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10387/045/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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