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Product No EMEA/H/C/000777
Brand Name Adenuric
Nonproprietary Name febuxostat
API febuxostat
ATC Code M04AA03
Indications 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). Adenuricis indicated in adults. 120 mg strength: Adenuricis 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). Adenuricis 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). Adenuricis indicated in adults.
Orphan Drug no
Generics no
Marketing Authorization Holder Menarini International Operations Luxembourg S.A. (MIOL)
Status Authorised
Authorization Date 2008-04-21
Version 13
Condition Approval no
Exceptions no
Biosimilar no
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