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.
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
ATC Code
M04AA03
ATC Item
febuxostat
Pharmacotherapeutic Group
Antigout preparations
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| febuxostat | N/A | 非布司他 |
EMA Name
Adenuric
Medicine Name
Adenuric
Aliases
N/A
