Authorised

Product identification

Medicine name:
Fasinex 5% w/v Oral Suspension
Active substance:
  • Triclabendazole
Target species:
  • Sheep
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Triclabendazole
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral suspension
Withdrawal period by route of administration:
  • Oral use
    • Sheep
      • Meat and offal
        55
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52AC
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • 12 litre HDPE containers
  • 2.2 litre HDPE containers
  • 0.8 litre HDPE containers

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Elanco France S.A.S
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA22020/004/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 8/04/2022
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000064231