This is a summary of the European public assessment report (EPAR) for Mepact. 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 Mepact.
Therapeutic Indication
### Therapeutic indication Mepact is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with postoperative multi-agent chemotherapy. Safety and efficacy have been assessed in studies of patients two to 30 years of age at initial diagnosis.
Therapeutic Area (MeSH)
ATC Code
L03AX15
ATC Item
mifamurtide
Pharmacotherapeutic Group
Immunostimulants
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| mifamurtide | N/A | Mifamurtide |
EMA Name
Mepact
Medicine Name
Mepact
Aliases
N/ANo risk management plan link.
