Authorised

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
Source URL: https://medicines.health.europa.eu/veterinary/600000048386