Veterinary Medicines

Betamox 150 mg/ml Suspension for Injection

Authorised
  • Amoxicillin trihydrate
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Product identification

Medicine name:
Betamox 150 mg/ml Suspension for Injection
Active substance:
  • Amoxicillin trihydrate
Target species:
  • Cattle
  • Sheep
  • Pig
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    172.21
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        18
        day
      • Milk
        48
        hour
    • Sheep
      • Meat and offal
        7
        day
    • Pig
      • Meat and offal
        14
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        18
        day
      • Milk
        48
        hour
    • Sheep
      • Meat and offal
        7
        day
    • Pig
      • Meat and offal
        14
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Available in:
  • Ireland
Package description:
  • The product is supplied in 100 ml Type II glass vial sealed with a nitryl bung and aluminium seal
  • The product is supplied in 50 ml Type II glass vial sealed with a nitryl bung and aluminium seal
  • The product is supplied in 50 ml plastic (PET) vial sealed with a nitryl bung and aluminium seal.
  • The product is supplied in 100 ml plastic (PET) vial sealed with a nitryl bung and aluminium seal.

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:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Manufacturing Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA22664/004/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

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