Not authorised

Product identification

Medicine name:
DECTOMAX 5 MG/ML POUR-ON SOLUTION FOR CATTLE
Dectomax Pour-On 5 mg/ml Pour-on oplossing
Dectomax 5 mg/ml Solution pour pour-on
Dectomax 5 mg/ml Lösung zum übergiessen
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
Authorisation status:
  • Surrendered
Authorised in:
  • Belgium
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
Marketing authorisation holder:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Elanco France S.A.S
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V192202
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.
Dutch (PDF)
Published on: 22/03/2022
French (PDF)
Published on: 22/03/2022

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
French (PDF)
Published on: 22/03/2022
German (PDF)
Published on: 22/03/2022

Source URL: https://medicines.health.europa.eu/veterinary/600000027522