Veterinary Medicines

Dobroxine 500 mg/g + 50 mg/g powder for use in drinking water/milk for calves

Authorised
  • Bromhexine hydrochloride
  • Doxycycline hyclate
Download as PDF

Product identification

Medicine name:
Dobroxine 500 mg/g + 50 mg/g powder for use in drinking water/milk for calves
Active substance:
  • Bromhexine hydrochloride
  • Doxycycline hyclate
Target species:
  • Cattle (pre-ruminant)
Route of administration:
  • In drinking water/milk use

Product details

Active substance and strength:
  • Bromhexine hydrochloride
    50.00
    milligram(s)
    /
    1.00
    gram(s)
  • Doxycycline hyclate
    596.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Powder for use in drinking water/milk
Withdrawal period by route of administration:
  • In drinking water/milk use
    • Cattle (pre-ruminant)
      • Meat and offal
        16
        day
    • Cattle (pre-ruminant)
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01AA20
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Cyprus
Package description:
  • Bag of 200 g
  • Bag of 1 Kg

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - known active substance (Article 8 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Laboratorios Karizoo S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Karizoo S.A.
Responsible authority:
  • Veterinary Services, Ministry Of Agriculture, Natural Resources And Environment
Authorisation number:
  • CY01001V
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0446/001
Concerned member states:
  • Cyprus
  • Italy
  • Netherlands
  • Portugal

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Greek (PDF)
Published on: 11/07/2025
Download

eu-PUAR-esv0446001-dcp-dobroxine-500-mg-g-+-50-mg-g-powder-for-use-in-drinking-water-milk-for-calves-en.pdf

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