Veterinary Medicines

Apravet 552 000 IU/g powder for use in drinking water/milk for pigs, calves, chickens and rabbits

Authorised
  • Apramycin sulfate
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Product identification

Medicine name:
Apravet 552 000 IU/g powder for use in drinking water/milk for pigs, calves, chickens and rabbits
Apravet WS 552.000 IE/g pulver til anvendelse i drikkevand/mælk
Active substance:
  • Apramycin sulfate
Target species:
  • Pig (weaned piglet)
  • Rabbit
  • Cattle (pre-ruminant)
  • Chicken (broiler)
Route of administration:
  • In drinking water/milk use

Product details

Active substance and strength:
  • Apramycin sulfate
    1.00
    milligram(s)
    /
    1.00
    milligram(s)
Pharmaceutical form:
  • Powder for use in drinking water/milk
Withdrawal period by route of administration:
  • In drinking water/milk use
    • Pig (weaned piglet)
      • Meat and offal
        0
        day
    • Rabbit
      • Meat and offal
        0
        day
    • Cattle (pre-ruminant)
      • Meat and offal
        28
        day
    • Chicken (broiler)
      • Meat and offal
        0
        day
      • 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
Available in:
  • Denmark
Package description:
  • bag containing 1811,6 g
  • box containing 50 sachets of 1,812 g
  • box containing 25 sachets of 1,812 g
  • 1 Sachet with 1,812g
  • bottle containing 90,58 g

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:
  • HuVepharma
Marketing authorisation date:
Manufacturing sites for batch release:
  • Biovet AD
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 57134
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0252/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 21/12/2023
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Danish (PDF)
Published on: 9/12/2025
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eu-PUAR-esv0252001-dcp-apravet-soluble-powder-en.pdf

English (PDF)
Published on: 21/12/2023
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