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Veterinary Medicines

Qualimec 10 mg/ml Solution for Injection.

Authorised
  • Ivermectin

Product identification

Medicine name:
Qualimec 10 mg/ml Solution for Injection.
Ivermax 10 mg/ml oplossing voor injectie
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
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
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
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:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 10446
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

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 27/12/2023

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
Download
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