Authorised

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
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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
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Source URL: https://medicines.health.europa.eu/veterinary/600000048752