Temodal
temozolomide
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Temodal. 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 Temodal.
Authorisation details
Product details | |
---|---|
Name |
Temodal
|
Agency product number |
EMEA/H/C/000229
|
Active substance |
temozolomide
|
International non-proprietary name (INN) or common name |
temozolomide
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01AX03
|
Publication details | |
---|---|
Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
|
Revision |
36
|
Date of issue of marketing authorisation valid throughout the European Union |
26/01/1999
|
Contact address |
Waarderweg 39 |
Product information
21/02/2023 Temodal - EMEA/H/C/000229 - IA/0099
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
Temodal hard capsules is indicated for the treatment of:
- adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy 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.