Veterinary Medicines

Orbenin LA 200 mg intramammary suspension for lactating cattle and sheep

Authorised
  • Cloxacillin sodium monohydrate
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Product identification

Medicine name:
Orbenin LA 200 mg intramammary suspension for lactating cattle and sheep
Orbenin lactation 200 mg intramammaire suspensie voor runderen en schapen
Active substance:
  • Cloxacillin sodium monohydrate
Target species:
  • Cattle (dairy cow)
  • Sheep
Route of administration:
  • Intramammary use

Product details

Active substance and strength:
  • Cloxacillin sodium monohydrate
    210.08
    milligram(s)
    /
    3.00
    gram(s)
Pharmaceutical form:
  • Intramammary suspension
Withdrawal period by route of administration:
  • Intramammary use
    • Cattle (dairy cow)
      • Milk
        96
        hour
      • Meat and offal
        7
        day
    • Sheep
      • Meat and offal
        7
        day
      • Milk
        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:
  • (ID1) 36 gram(s): unspecified outer container with 12 Syringe (Low Density PolyEthylene) each with 3 gram(s)

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:
  • 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 116383
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0319/001
Concerned member states:
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Spain

Documents

Combined File of all Documents

English (PDF)
Published on: 5/06/2023
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Dutch (PDF)
Published on: 7/02/2022
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