Authorised

Product identification

Medicine name:
Qualimec 10 mg/ml Solution for Injection.
QUALIMEC 10 MG/ML SOLUTION INJECTABLE
Active substance:
  • Ivermectin
Target species:
  • Cattle
  • Sheep
  • Pig
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Ivermectin
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        49
        day
    • Sheep
      • Meat and offal
        42
        day
    • Pig
      • Meat and offal
        28
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • Clear PET multidose container with bromobutyl rubber stopper and aluminium cap. Pack size 50 ml
  • HDPE multidose container with bromobutyl rubber stopper and aluminium cap.Pack size: 200 ml
  • Clear PET multidose container with bromobutyl rubber stopper and aluminium cap. Pack size 500 ml
  • HDPE multidose container with bromobutyl rubber stopper and aluminium cap.Pack size: 500 ml.
  • HDPE multidose container with bromobutyl rubber stopper and aluminium cap.Pack size: 50 ml
  • Clear PET multidose container with bromobutyl rubber stopper and aluminium cap. Pack size 250 ml

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:
  • Produlab Pharma B.V.
  • Divasa Farmavic S.A.
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/2968829 8/2004
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0145/001
Concerned member states:
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Luxembourg
  • Netherlands
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
Download
French (PDF)
Published on: 26/05/2023
Download

Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 22/05/2023
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000048702