Authorised

Product identification

Medicine name:
Macromectin 0.8 mg/ml oral solution for sheep
Noromectin vet 0,8 mg/ml Oral lösning
Active substance:
  • Ivermectin
Target species:
  • Sheep
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Ivermectin
    0.80
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Sheep
      • Meat and offal
        10
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Sweden
Package description:
  • The product will be supplied in 1.0 L high density polyethylene back-pack containers complete with polypropylene plastic screw caps.
  • The product will be supplied in 2.5 L high density polyethylene jerry-can containers complete with polypropylene caps
  • The product will be supplied in 5.0 L high density polyethylene back-pack containers complete with polypropylene plastic screw caps.
  • The product will be supplied in 2 x 5.0 L high density polyethylene back-pack containers complete with polypropylene plastic screw caps.
  • The product will be supplied in 2.5 L high density polyethylene back-pack containers complete with polypropylene plastic screw caps.
  • The product will be supplied in 2 x 5.0 L high density polyethylene jerry-can containers complete with polypropylene caps
  • The product will be supplied in 5.0 L high density polyethylene jerry-can containers complete with polypropylene caps
  • The product will be supplied in 1.0 L high density polyethylene jerry-can containers complete with polypropylene caps

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:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Norbrook Manufacturing Limited
Responsible authority:
  • Swedish Medical Products Agency
Authorisation number:
  • 23313
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0179/001
Concerned member states:
  • Sweden

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
Download
Swedish (PDF)
Published on: 2/05/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 2/05/2022
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000048199