This is a summary of the European public assessment report (EPAR) for Mycamine. 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 Mycamine.
Therapeutic Indication
### Therapeutic indication Mycamine is indicated for: **Adults, adolescents ≥ 16 years of age and elderly** - treatment of invasive candidiasis; - treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate; - prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days. **Children (including neonates) and adolescents < 16 years of age** - treatment of invasive candidiasis. - prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days. The decision to use Mycamine should take into account a potential risk for the development of liver tumours. Mycamine should therefore only be used if other antifungals are not appropriate.
Therapeutic Area (MeSH)
ATC Code
J02AX05
ATC Item
micafungin
Pharmacotherapeutic Group
Antimycotics for systemic use
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| micafungin | N/A | 米卡芬净 |
EMA Name
Mycamine
Medicine Name
Mycamine
Aliases
N/A
