Temozolomide Teva

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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). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 18/02/2022

Authorisation details

Product details
Name
Temozolomide Teva
Agency product number
EMEA/H/C/001126
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
Teva B.V. 
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
28/01/2010
Contact address
Teva B.V.
Swensweg 5
203-GA Haarlem
The Netherlands

Product information

18/02/2022 Temozolomide Teva - EMEA/H/C/001126 - IB/0037

Other EU languages available icon 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:

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

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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