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AMPIDEXALONE, suspensie injectabilă pentru bovine, cai și porci

Authorised
  • Dexamethasone
  • Colistin
  • Amoxicillin
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Product identification

Medicine name:
AMPIDEXALONE, suspensie injectabilă pentru bovine, cai și porci
Active substance:
  • Dexamethasone
  • Colistin
  • Amoxicillin
Target species:
  • Pig
  • Horse
  • Cattle
Route of administration:
  • Subcutaneous use
  • Intramuscular use
  • Intraperitoneal use

Product details

Active substance and strength:
  • Dexamethasone
    0.25
    milligram(s)
    /
    1.00
    millilitre(s)
  • Colistin
    250000.00
    international unit(s)
    /
    1.00
    millilitre(s)
  • Amoxicillin
    87.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Pig
      • Meat and offal
        21
        day
    • Horse
      • Meat and offal
        21
        day
    • Cattle
      • Meat and offal
        21
        day
      • Milk
        5
        day
  • Intramuscular use
    • Pig
      • Meat and offal
        21
        day
    • Horse
      • Meat and offal
        21
        day
    • Cattle
      • Meat and offal
        21
        day
      • Milk
        5
        day
  • Intraperitoneal use
    • Pig
      • Meat and offal
        21
        day
    • Horse
      • Meat and offal
        21
        day
    • Cattle
      • Meat and offal
        21
        day
      • Milk
        5
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01RV01
Legal status of supply:
This information is not available for this product.
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:
  • Dopharma Research B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dopharma France
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 190243
Date of authorisation status change:

Documents

Combined File of all Documents

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Romanian (PDF)
Published on: 6/02/2025
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