Veterinary Medicines

RESETYL prášok na perorálny roztok

Authorised
  • Tylosin tartrate
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Product identification

Medicine name:
RESETYL prášok na perorálny roztok
Active substance:
  • Tylosin tartrate
Target species:
  • Chicken
  • Turkey
  • Pig
  • Cattle (calf)
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Tylosin tartrate
    1100.00
    gram(s)
    /
    1100.00
    gram(s)
Pharmaceutical form:
  • Powder for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Chicken
      • Meat and offal
        1
        day
      • Eggs
        0
        day
    • Turkey
      • Meat and offal
        5
        day
    • Cattle (calf)
      • Meat and offal
        10
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA90
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:
  • Full application - Known active substance (Article 12(3) of Directive No 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:
  • 96/014/10-S
Date of authorisation status change:

Documents

Combined File of all Documents

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Slovak (PDF)
Published on: 9/08/2023
Updated on: 10/08/2023
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