Basic Information
Temozolomide Sun
Regulatory Information
EMEA/H/C/002198
July 13, 2011
20
May 21, 2024
Company Information
the netherlands
Polarisavenue 87 2132 JH Hoofddorp
Sun Pharmaceutical Industries (Europe) B.V.
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Temozolomide Sun 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 Temozolomide Sun. 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 Temozolomide Sun.