Febuxostat Mylan

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febuxostat

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Febuxostat Mylan. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Febuxostat Mylan.

For practical information about using Febuxostat Mylan, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 19/10/2017

Authorisation details

Product details
Name
Febuxostat Mylan
Agency product number
EMEA/H/C/004374
Active substance
febuxostat
International non-proprietary name (INN) or common name
febuxostat
Therapeutic area (MeSH)
  • Hyperuricemia
  • Arthritis, Gouty
  • Gout
Anatomical therapeutic chemical (ATC) code
M04AA03
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Mylan S.A.S
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
14/06/2017
Contact address

117 Allee des Parcs
69800
Saint-Priest
France

Product information

15/06/2017 Febuxostat Mylan - EMEA/H/C/004374 - -

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTIGOUT PREPARATIONS

Therapeutic indication

Febuxostat Mylan is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).

Febuxostat Mylan is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).

Febuxostat Mylan is indicated in adults.

Assessment history

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