Veterinary Medicines Information website

Flubendazole Elanco 50 mg/g oral powder for pigs

Authorised
  • Flubendazole
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Product identification

Medicine name:
Flubendazole Elanco 50 mg/g oral powder for pigs
Active substance:
  • Flubendazole
Target species:
  • Pig
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Flubendazole
    50.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Oral powder
Withdrawal period by route of administration:
  • Oral use
    • Pig
      • Meat and offal
        7
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52AC12
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Available in:
  • France
Package description:
  • 600 g polypropylene container closed with a low density polyethylene (LDPE) push cap. The product is accompanied with a polypropylene spoon

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:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Elanco France S.A.S.
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/9438166 7/2013
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0292/001
Concerned member states:
  • France
  • Poland

Documents

Summary of Product Characteristics

English (PDF)
Published on: 29/12/2024
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French (PDF)
Published on: 5/03/2025
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Combined File of all Documents

English (PDF)
Published on: 29/12/2024
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Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 4/03/2025
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ie-puar-mr-iev0292001-flubendazole-elanco-50-mgg-oral-powder-for-pigs-en.pdf

English (PDF)
Published on: 30/08/2026
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