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OPTIPRIME, pulbere orală pentru administrare în apa de băut

Authorised
  • Trimethoprim
  • Sulfadiazine
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Product identification

Medicine name:
OPTIPRIME, pulbere orală pentru administrare în apa de băut
Active substance:
  • Trimethoprim
  • Sulfadiazine
Target species:
  • Cattle (calf)
  • Pig (weaned piglet)
  • Sheep (lamb)
  • Horse (foal)
Route of administration:
  • In drinking water/milk use

Product details

Active substance and strength:
  • Trimethoprim
    20.00
    milligram(s)
    /
    1.00
    gram(s)
  • Sulfadiazine
    100.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Powder for use in drinking water/milk
Withdrawal period by route of administration:
  • In drinking water/milk use
    • Cattle (calf)
      • Meat and offal
        5
        day
    • Pig (weaned piglet)
      • Meat and offal
        5
        day
    • Sheep (lamb)
      • Meat and offal
        5
        day
    • Horse (foal)
      • Meat and offal
        5
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01EW10
Legal status of supply:
This information is not available for this product.
Authorisation status:
  • Valid
Authorised in:
  • Romania
Available 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:
  • PROVET S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Provet S.A.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 220112
Date of authorisation status change:

Documents

Combined File of all Documents

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Romanian (PDF)
Published on: 26/08/2024
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