Veterinary Medicines

Ecomectin 10 mg/ml Solution for Injection

Authorised
  • Ivermectin
Download as PDF

Product identification

Medicine name:
Ecomectin 10 mg/ml Solution for Injection
Ecomectin 10 mg/ml solução injectável para bovinos, suínos e ovinos
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
        42
        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:
  • Portugal
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:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 51517
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0144/001
Concerned member states:
  • Austria
  • Belgium
  • Estonia
  • France
  • Germany
  • Greece
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Portuguese (PDF)
Published on: 2/02/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."