Veterinary Medicine Information website

AMPROLINE 400 MG/ML SOLUTION FOR USE IN DRINKING WATER FOR CHICKENS AND TURKEYS

Authorised
  • Amprolium hydrochloride
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Product identification

Medicine name:
AMPROLINE 400 MG/ML SOLUTION FOR USE IN DRINKING WATER FOR CHICKENS AND TURKEYS
Active substance:
  • Amprolium hydrochloride
Target species:
  • Turkey
  • Chicken (pullet for egg production, future layer)
  • Chicken (for reproduction)
  • Chicken (broiler)
  • Chicken (layer hen)
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Amprolium hydrochloride
    452.40
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for use in drinking water
Withdrawal period by route of administration:
  • Oral use
    • Turkey
      • Eggs
        0
        day
      • Meat and offal
        0
        day
    • Chicken (pullet for egg production, future layer)
      • Eggs
        0
        day
      • Meat and offal
        0
        day
    • Chicken (for reproduction)
      • Eggs
        0
        day
      • Meat and offal
        0
        day
    • Chicken (broiler)
      • Meat and offal
        0
        day
    • Chicken (layer hen)
      • Eggs
        0
        day
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP51AX09
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Available in:
  • Bulgaria
Package description:
  • 1 L can
  • 5 L can
  • 100 mL can

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Huvepharma S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Huvepharma S.A.
  • Biovet AD
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-2920
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0284/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 2/01/2024
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Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 2/01/2024
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Combined File of all Documents

English (PDF)
Published on: 14/03/2026
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eu-puar-frv0284001-mr-rpe234-en.pdf

English (PDF)
Published on: 13/03/2026
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