Basic Information
Temomedac
Regulatory Information
EMEA/H/C/001124
January 25, 2010
November 19, 2009
15
March 28, 2022
Company Information
Germany
Theaterstrasse 6 22880 Wedel
medac Gesellschaft für klinische Spezialpräparate mbH
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
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.
Overview Summary
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.