Temozolomide Hexal

Withdrawn

This medicine's authorisation has been withdrawn

temozolomide

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 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.

Authorisation details

• EMA product number:
  EMEA/H/C/001127
• 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.

• Marketing authorisation holder:
  Hexal AG

  Industriestrasse 25; D-83607 Holzkirchen; Germany

• Marketing authorisation issued:
  15/03/2010
• Revision:
  17

Assessment history

Changes since initial authorisation of medicine

Temozolomide Hexal : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Temozolomide Hexal : EPAR - Public assessment report

CHMP summary of positive opinion for Temozolomide Hexal

AdoptedReference Number: EMA/CHMP/810041/2009