Overview
This is a summary of the European Public Assessment Report (EPAR) for Temozolomide Hexal. 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 Hexal.
Temozolomide Hexal : EPAR - Summary for the public
Product information
Temozolomide Hexal : EPAR - Product Information
Latest procedure affecting product information: IB/0037
15/09/2022
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Temozolomide Hexal : EPAR - All Authorised presentations
Product details
- Name of medicine
- Temozolomide Hexal
- Active substance
- temozolomide
- International non-proprietary name (INN) or common name
- temozolomide
- Therapeutic area (MeSH)
- Glioma
- Glioblastoma
- Anatomical therapeutic chemical (ATC) code
- L01AX03
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
For the treatment of 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.
Assessment history
Temozolomide Hexal : EPAR - Procedural steps taken and scientific information after authorisation