Adenuric

RSS

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 Adenuric. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Adenuric.

This EPAR was last updated on 27/06/2018

Authorisation details

Product details
Name
Adenuric
Agency product number
EMEA/H/C/000777
Active substance
febuxostat
International non-proprietary name (INN) or common name
febuxostat
Therapeutic area (MeSH)
Gout
Anatomical therapeutic chemical (ATC) code
M04AA03
Publication details
Marketing-authorisation holder
Menarini International Operations Luxembourg S.A. (MIOL)
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
21/04/2008
Contact address
1 Avenue de la Gare
L-1611 Luxembourg

Product information

31/05/2018 Adenuric - EMEA/H/C/000777 - II/0047

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

80 mg strength:

Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).

Adenuric is indicated in adults.

120 mg strength:

Adenuric 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).

Adenuric 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).

Adenuric is indicated in adults.

Assessment history

Changes since initial authorisation of medicine

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