Veterinary Medicines

GENTAMOX

Authorised
  • Amoxicillin trihydrate
  • Gentamicin sulfate
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Product identification

Medicine name:
GENTAMOX
Active substance:
  • Amoxicillin trihydrate
  • Gentamicin sulfate
Target species:
  • Cattle
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    150.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Gentamicin sulfate
    65.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        30
        day
      • Milk
        2
        day
    • Pig
      • Meat and offal
        30
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01RA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:

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:
  • Laboratorios Hipra S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Hipra S.A.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 160356
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Romanian (PDF)
Published on: 23/12/2021
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