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ДЕКСАМЕТАЗОН БИОФАРМ 0,4% инжекционен разтвор

Authorised
  • Dexamethasone sodium phosphate
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Product identification

Medicine name:
ДЕКСАМЕТАЗОН БИОФАРМ 0,4% инжекционен разтвор
Active substance:
  • Dexamethasone sodium phosphate
Target species:
  • Cattle
  • Horse
  • Pig
  • Dog
  • Cat
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Dexamethasone sodium phosphate
    4.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        21
        day
      • Milk
        5
        day
    • Horse
      • Meat and offal
        21
        day
    • Pig
      • Meat and offal
        21
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH02AB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Sopharma AD
Marketing authorisation date:
Manufacturing sites for batch release:
  • Sopharma AD
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-3089
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Bulgarian (PDF)
Published on: 5/03/2026
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