Temodal

RSS

temozolomide

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 03/09/2018

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)
  • Glioma
  • Glioblastoma
Anatomical therapeutic chemical (ATC) code
L01AX03
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V. 
Revision
31
Date of issue of marketing authorisation valid throughout the European Union
26/01/1999
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

23/08/2018 Temodal - EMEA/H/C/000229 - T/0083

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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