Veterinary Medicines

Noromectin 18.7 mg/g Oral Paste for Horses

Authorised
  • Ivermectin
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Product identification

Medicine name:
Noromectin 18.7 mg/g Oral Paste for Horses
NOROMECTIN 1,87 % PATE ORALE POUR CHEVAUX
Active substance:
  • Ivermectin
Target species:
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Ivermectin
    1.87
    gram(s)
    /
    100.00
    gram(s)
Pharmaceutical form:
  • Oral paste
Withdrawal period by route of administration:
  • Oral use
    • Horse
      • Meat and offal
        34
        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:
  • Low-density polyethylene pre-filled syringes containing 7.49 g of product in cartons of 1 syringe.
  • Low-density polyethylene pre-filled syringes containing 7.49 g of product in cartons of 2 syringes.
  • Low-density polyethylene pre-filled syringes containing 7.49 g of product in cartons of 10 syringes.
  • Low-density polyethylene pre-filled syringes containing 7.49 g of product in cartons of 50 syringes.

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 Manufacturing Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/6357754 3/2005
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0124/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Iceland
  • Italy
  • Luxembourg
  • Netherlands
  • Portugal
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2024
Download
French (PDF)
Published on: 27/09/2023
Download

Combined File of all Documents

English (PDF)
Published on: 22/12/2024
Download

ie-puar-mr-iev0124001-noromectin-187-oral-paste-for-horses-en.pdf

English (PDF)
Published on: 22/12/2024
Download
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