Veterinary Medicines

Paramectin 5 mg/ml Pour-On Solution for cattle

Authorised
  • Ivermectin
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Product identification

Medicine name:
Paramectin 5 mg/ml Pour-On Solution for cattle
PARAMECTIN POUR-ON 5 mg/ml SOLUCION PARA UNCION DORSAL CONTINUA PARA BOVINO
Active substance:
  • Ivermectin
Target species:
  • Cattle
Route of administration:
  • Pour-on use

Product details

Active substance and strength:
  • Ivermectin
    0.50
    gram(s)
    /
    100.00
    millilitre(s)
Pharmaceutical form:
  • Pour-on solution
Withdrawal period by route of administration:
  • Pour-on 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:
  • Spain
Available in:
  • Spain
Package description:
  • The product will be supplied in 250 ml twin-neck, squeeze-measure high density polyethylene dispensers.
  • The product will be supplied in 1.0L single-neck high density polyethylene dispensers.
  • The product will be supplied in 2.5L low density polyethylene backpacks
  • The product will be supplied in 5 L low density polyethylene backpacks
  • The product will be supplied in 250 ml single-neck high density polyethylene dispensers.
  • The product will be supplied in 1.0 L twin-neck, squeeze-measure high density polyethylene dispensers.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Informed consent (abridged application) - Council Directive 81/851/EEC
Marketing authorisation holder:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Manufacturing Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 1441 ESP
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0118/001
Concerned member states:
  • Italy
  • Luxembourg
  • Portugal
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2024
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Spanish (PDF)
Published on: 13/12/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 13/12/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 5/03/2025
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Combined File of all Documents

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