Adenuric
febuxostat
Table of contents
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.
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List item
Adenuric : EPAR - Summary for the public (PDF/78.64 KB)
First published: 07/09/2009
Last updated: 19/05/2015 -
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List item
Adenuric : EPAR - Risk Management Plan (PDF/1.69 MB)
First published: 20/04/2023
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 | |
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Marketing-authorisation holder |
Menarini International Operations Luxembourg S.A. (MIOL)
|
Revision |
23
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Date of issue of marketing authorisation valid throughout the European Union |
21/04/2008
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Contact address |
1 Avenue de la Gare
L-1611 Luxembourg |
Product information
08/08/2022 Adenuric - EMEA/H/C/000777 - IB/0069
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.