Veterinary Medicines

HELMIGAL 50 mg/ml perorálna suspenzia

Authorised
  • Fenbendazole
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Product identification

Medicine name:
HELMIGAL 50 mg/ml perorálna suspenzia
Active substance:
  • Fenbendazole
Target species:
  • Cattle
  • Sheep
  • Goat
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Fenbendazole
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral suspension
Withdrawal period by route of administration:
  • Oral use
    • Cattle
      • Meat and offal
        7
        day
      • Milk
        84
        hour
    • Sheep
      • Meat and offal
        14
        day
      • Milk
        84
        hour
    • Goat
      • Meat and offal
        14
        day
      • Milk
        48
        hour
    • Horse
      • All relevant tissues
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52AC13
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
  • Pharmagal spol. s r.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Pharmagal spol. s r.o.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/002/00-S
Date of authorisation status change:

Documents

Combined File of all Documents

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Slovak (PDF)
Published on: 12/05/2022
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