Temozolomide Accord

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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 Accord. 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 Accord.

This EPAR was last updated on 21/03/2019

Authorisation details

Product details
Name
Temozolomide Accord
Agency product number
EMEA/H/C/001125
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
Accord Healthcare S.L.U.
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
15/03/2010
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

25/02/2019 Temozolomide Accord - EMEA/H/C/001125 - T/0045

Contents

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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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