Febuxostat Krka

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febuxostat

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

Overview

Febuxostat Krka is a medicine used to treat adults with long-term hyperuricaemia (high levels of uric acid or ‘urate’ in the blood). Hyperuricaemia can lead to urate crystals forming and building up in the joints and the kidneys. When this happens in the joints and causes pain, it is known as ‘gout’. Febuxostat Krka is used in patients who have signs of a build-up of crystals, including gouty arthritis (pain and inflammation in the joints) or tophi (‘stones’, larger deposits of urate crystals that can cause joint and bone damage).

Febuxostat Krka is also used to treat and prevent high levels of uric acid in the blood in adults with blood cancers who are receiving chemotherapy (medicines to treat cancer) and at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells causing a sudden rise of uric acid in the blood which can cause damage to the kidneys).

Febuxostat Krka contains the active substance febuxostat and is a ‘generic medicine’. This means that Febuxostat Krka contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Adenuric.

This EPAR was last updated on 29/03/2019

Authorisation details

Product details
Name
Febuxostat Krka
Agency product number
EMEA/H/C/004773
Active substance
febuxostat
International non-proprietary name (INN) or common name
febuxostat
Therapeutic area (MeSH)
  • Hyperuricemia
  • Gout
Anatomical therapeutic chemical (ATC) code
M04AA03
GenericGeneric

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
Krka, d.d., Novo mesto
Date of issue of marketing authorisation valid throughout the European Union
28/03/2019
Contact address

KRKA d.d., Novo mesto
Šmarješka cesta 6
SI-8501 Novo mesto
Slovenia

Product information

28/03/2019 Febuxostat Krka - EMEA/H/C/004773 -

Contents

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Pharmacotherapeutic group

ANTIGOUT PREPARATIONS

Therapeutic indication

Febuxostat Krka 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 Krka is indicated in adults.

Assessment history

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