Temozolomide Hexal

Withdrawn

This medicine's authorisation has been withdrawn

temozolomide

Overview

On 15 September 2022, the European Commission withdrew the marketing authorisation for Temozolomide Hexal (temozolomide) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Hexal AG, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Temozolomide Hexal was granted marketing authorisation in the EU on 15 March 2010 for treatment of:

• adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) 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. 

The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2014. Temozolomide Hexal is a generic medicine of Temodal. There are other generic medicinal products of Temodal authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Temozolomide Hexal is updated to indicate that the marketing authorisation is no longer valid.

Temozolomide Hexal : EPAR - Summary for the public

Product information

Temozolomide Hexal : EPAR - Product Information

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
• 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