Temozolomide Hexal
temozolomide
Table of contents
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.
Authorisation details
| Product details | |
|---|---|
| Name |
Temozolomide Hexal
|
| Agency product number |
EMEA/H/C/001127
|
| Active substance |
temozolomide
|
| International non-proprietary name (INN) or common name |
temozolomide
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
L01AX03
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Hexal AG
|
| Revision |
17
|
| Date of issue of marketing authorisation valid throughout the European Union |
15/03/2010
|
| Contact address |
Industriestrasse 25
D-83607 Holzkirchen Germany |
Product information
15/09/2022 Temozolomide Hexal - EMEA/H/C/001127 - IB/0037
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic 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.