This is a summary of the European public assessment report (EPAR) for Temomedac. 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 Temomedac.
Therapeutic Indication
### Therapeutic indication Temomedac hard capsules is indicated for the treatment of: - adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment; - children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Therapeutic Area (MeSH)
ATC Code
L01AX03
ATC Item
temozolomide
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| temozolomide | N/A | 替莫唑胺 |
EMA Name
Temomedac
Medicine Name
Temomedac
Aliases
N/ANo risk management plan link.
