Temozolomide Hexal

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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 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.

This EPAR was last updated on 16/10/2019

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)
  • Glioma
  • Glioblastoma
Anatomical therapeutic chemical (ATC) code
L01AX03
GenericGeneric

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
15
Date of issue of marketing authorisation valid throughout the European Union
15/03/2010
Contact address
Industriestrasse 25
D-83607 Holzkirchen
Germany

Product information

27/09/2019 Temozolomide Hexal - EMEA/H/C/001127 - IAIN/0034

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

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

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