This is a summary of the European public assessment report (EPAR) for Fasturtec. 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 Fasturtec.
Therapeutic Indication
Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in adults, children and adolescents (aged 0 to 17 years) with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.
Therapeutic Area (MeSH)
ATC Code
V03AF07
ATC Item
N/A
Pharmacotherapeutic Group
All other therapeutic products
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| rasburicase | N/A | rasburicase |
EMA Name
Fasturtec
Medicine Name
Fasturtec
Aliases
N/ANo risk management plan link.