Authorised

Product identification

Medicine name:
Ecomectin 5 mg/ml Pour-on Solution for Cattle
Ecomectin 5 mg/ml pour-on oplossing Pour-on oplossing
Ecomectin 5 mg/ml solution pour pour-on Solution pour pour-on
Ecomectin 5 mg/ml Lösung zum Übergiessen Lösung zum übergiessen
Active substance:
  • Ivermectin
Target species:
  • Cattle
Route of administration:
  • Pour-on use

Product details

Active substance and strength:
  • Ivermectin
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Pour-on solution
Withdrawal period by route of administration:
  • Pour-on use
    • Cattle
      • Meat and offal
        31
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • 5.0 L white non-fluorinated or fluorinated high-density polyethylene back-pack with polypropylene strap and vented capClosure: White polypropylene screw-cap.
  • 2.5 L white non-fluorinated or fluorinated high-density polyethylene back-pack with polypropylene strap and vented capClosure: White polypropylene screw-cap.
  • 1.0 L white non-fluorinated or fluorinated high-density polyethylene bottle with a drawing tube and measuring device.Closure: White polypropylene screw-cap.
  • 250 ml white non-fluorinated or fluorinated high-density polyethylene bottle with a drawing tube and measuring device.Closure: White polypropylene screw-cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Eco Animal Health Europe Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Acme Drugs S.r.l.
  • Safapac Limited
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V226387
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0108/001
Concerned member states:
  • Belgium
  • France
  • Germany
  • Greece
  • Italy
  • Portugal
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 26/08/2024
Download
Dutch (PDF)
Published on: 22/03/2022
Download
French (PDF)
Published on: 22/03/2022
Download

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
Download
French (PDF)
Published on: 22/03/2022
Download
German (PDF)
Published on: 22/03/2022
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000048716