Veterinary Medicines

DOPHEXINE 20 MG/G POWDER FOR USE IN DRINKING WATER/MILK

Authorised
  • Bromhexine hydrochloride
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Product identification

Medicine name:
DOPHEXINE 20 MG/G POWDER FOR USE IN DRINKING WATER/MILK
Dophexine, 20mg/g, Prášek pro podání v pitné vodě/mléce
Active substance:
  • Bromhexine hydrochloride
Target species:
  • Turkey
  • Pig
  • Duck
  • Chicken
  • Chicken (broiler)
  • Cattle
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Bromhexine hydrochloride
    20.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Powder for use in drinking water/milk
Withdrawal period by route of administration:
  • Oral use
    • Turkey
      • Meat and offal
        0
        day
      • Eggs
        no withdrawal period
    • Pig
      • Meat and offal
        0
        day
    • Duck
      • Meat and offal
        0
        day
      • Eggs
        no withdrawal period
    • Chicken
      • Eggs
        no withdrawal period
    • Chicken (broiler)
      • Meat and offal
        0
        day
    • Cattle
      • Meat and offal
        2
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QR05CB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Available in:
  • Czechia
Package description:
  • Composite can of 1 kg
  • Bucket of 5 kg
  • Bucket of 2,5 kg
  • Bucket of 1 kg
  • Securitainer of 1 kg

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:
  • Dopharma Research B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dopharma B.V.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/042/21-C
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0391/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • Sweden

Documents

Summary of Product Characteristics

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Czech (PDF)
Published on: 2/01/2026
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Package Leaflet

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Czech (PDF)
Published on: 2/01/2026
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 2/01/2026
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