Veterinary Medicines

Macromectin 0.5% w/v Pour-On Solution

Authorised
  • Ivermectin
Download as PDF

Product identification

Medicine name:
Macromectin 0.5% w/v Pour-On Solution
BAYMEC 0,5% SOLUTION POUR-ON
Active substance:
  • Ivermectin
Target species:
  • Cattle
Route of administration:
  • Topical 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:
  • Topical use
    • Cattle
      • 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:
  • The product will be supplied in: 250 ml twin-neck high density polyethylene dispensers
  • The product will be supplied in:1.0 L single-neck high density polyethylene dispensers
  • The product will be supplied in:2.5 L low density polyethylene backpacks.
  • The product will be supplied in:5 L low density polyethylene backpacks.
  • The product will be supplied in: 250 ml squeeze-measure high density polyethylene dispensers
  • The product will be supplied in:1.0 L squeeze-measure high density polyethylene dispensers
  • The product will be supplied in:250 ml single-neck high density polyethylene dispensers
  • The product will be supplied in:1 L high density polyethylene backpacks.
  • The product will be supplied in: 1.0 L twin-neck high density polyethylene dispensers

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Norbrook Manufacturing Limited
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/0681919 0/2006
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0180/001
Concerned member states:
  • France

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
Download
French (PDF)
Published on: 27/02/2023
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."