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Entemulin 450 mg/g, granule za oralnu otopinu, za svinje, kokoši i purane

Authorised
  • Tiamulin hydrogen fumarate
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Product identification

Medicine name:
Entemulin 450 mg/g, granule za oralnu otopinu, za svinje, kokoši i purane
Active substance:
  • Tiamulin hydrogen fumarate
Target species:
  • Pig
  • Chicken
  • Turkey
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Tiamulin hydrogen fumarate
    450.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Granules for oral solution
Withdrawal period by route of administration:
  • Oral use
    • Pig
      • Meat and offal
        2
        day
    • Chicken
      • Meat and offal
        2
        day
    • Turkey
      • Meat and offal
        6
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01XQ01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Croatia
Available in:
  • Croatia
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Krka-Farma d.o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/17-01/289
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Croatian (PDF)
Published on: 29/07/2025
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