Veterinary Medicines

Paramectin 10 mg/ml Solution for Injection

Authorised
  • Ivermectin
Download as PDF

Product identification

Medicine name:
Paramectin 10 mg/ml Solution for Injection
Paramectin 1% Soluzione iniettabile per bovini e suini
Active substance:
  • Ivermectin
Target species:
  • Cattle
  • Pig
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Ivermectin
    1.00
    gram(s)
    /
    100.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        49
        day
    • Pig
      • Meat and offal
        18
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • The product will be supplied in 50 ml volume, presented in high density polyethylene vial with bromobutyl bung and aluminium cap.
  • The product will be supplied in 100 ml volume, presented in high density polyethylene vial with bromobutyl bung and aluminium cap.
  • The product will be supplied in 250 ml volume, presented in high density polyethylene vial with bromobutyl bung and aluminium cap.
  • The product will be supplied in 500 ml volume, presented in high density polyethylene vial with bromobutyl bung and aluminium cap.
  • The product will be supplied in 1 litre volume, presented in high density polyethylene vial with bromobutyl bung and aluminium cap.

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 Manufacturing Ltd
  • Norbrook Laboratories Limited
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 103303
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0119/001
Concerned member states:
  • Greece
  • Italy
  • Portugal
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 29/12/2024
Download
Italian (PDF)
Published on: 29/07/2024
Download

Combined File of all Documents

English (PDF)
Published on: 29/12/2024
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."