Veterinary Medicines

Apravet Soluble Powder

Authorised
  • Apramycin sulfate
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Product identification

Medicine name:
Apravet Soluble Powder
Apravet 552 UI/mg polvere per somministrazione in acqua da bere/latte per suini vitelli, polli e conigli
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:
  • Italy
Package description:
  • box containing 50 sachets of 1,812 g
  • box containing 25 sachets of 1,812 g
  • bottle containing 90,58 g
  • bag containing 1811,6 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 J.S.C.
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 104991
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

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Italian (PDF)
Published on: 28/06/2022
Download

Summary of Product Characteristics

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

eu-PUAR-esv0252001-dcp-apravet-soluble-powder-en.pdf

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