File downloaded on 2026-01-20
Source URL: https://medicines.health.europa.eu/veterinary/en/600000027540
Not authorised

Product identification

Medicine name:
ZEARL POUR-ON
DECTOMAX 5 MG/ML POUR-ON SOLUTION FOR CATTLE
Active substance:
  • Doramectin
Target species:
  • Cattle
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Doramectin
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Pour-on solution
Withdrawal period by route of administration:
  • Cutaneous use
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        35
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • France
Package description:
  • 1 L bottle
  • 2.5 L bottle and draw-off adaptor
  • 5 L bottle and draw-off adaptor
  • 3 L bottle and draw-off adaptor
  • 250 ml bottle

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Elanco France S.A.S.
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/1225541 8/1998
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0343/001

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 4/04/2022
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