Veterinary Medicines

VETIPRACIN 250 IU/MG POWDER FOR USE IN DRINKING WATER/MILK REPLACER

Authorised
  • Apramycin sulfate
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Product identification

Medicine name:
VETIPRACIN 250 IU/MG POWDER FOR USE IN DRINKING WATER/MILK REPLACER
Vetipracin 250.000 IE/g pulver til anvendelse i drikkevand/mælk
Active substance:
  • Apramycin sulfate
Target species:
  • Chicken (broiler)
  • Rabbit
  • Pig (weaned piglet)
  • Cattle (pre-ruminant)
Route of administration:
  • In drinking water/milk use

Product details

Active substance and strength:
  • Apramycin sulfate
    250000.00
    international unit(s)/gram
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Powder for use in drinking water/milk
Withdrawal period by route of administration:
  • In drinking water/milk use
    • Chicken (broiler)
      • Meat and offal
        0
        day
    • Rabbit
      • Meat and offal
        0
        day
    • Pig (weaned piglet)
      • Meat and offal
        0
        day
    • Cattle (pre-ruminant)
      • Meat and offal
        28
        day
    • Chicken (broiler)
      • Eggs
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA07AA92
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • Bag of 1 kg

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application - change in active substance(s) (Article 19(1)(a) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Laboratorios Maymo S.A.U.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Maymo S.A.U.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 71392
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0442/001
Concerned member states:
  • Bulgaria
  • Denmark
  • France
  • Portugal

Documents

Summary of Product Characteristics

English (PDF)
Published on: 5/06/2025
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Package Leaflet

English (PDF)
Published on: 5/06/2025
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eu-PUAR-esv0442001-dcp-vetipracin-250-iu-mg-powder-for-use-in-drinking-water-milk-replacer-en.pdf

English (PDF)
Published on: 24/07/2025
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