Temomedac

Authorised

This medicine is authorised for use in the European Union

temozolomide

Overview

This is a summary of the European public assessment report (EPAR) for Temomedac. 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 Temomedac.

What is Temomedac?

Temomedac is a cancer medicine that contains the active substance temozolomide. It is available as capsules (5, 20, 100, 140, 180 and 250 mg).

Temomedac is a ‘generic medicine’. This means that Temomedac is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Temodal.

What is Temomedac used for?

Temomedac is used to treat malignant glioma (brain tumours) in the following groups of patients:

• adults with newly diagnosed glioblastoma multiforme (an aggressive type of brain tumour). Temomedac is used first with radiotherapy and then on its own;
• adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment. Temomedac is used on its own in these patients.

The medicine can only be obtained with a prescription.

How is Temomedac used?

Treatment with Temomedac should be prescribed by a doctor with experience in the treatment of brain tumours.

The dose of Temomedac depends on body surface area (calculated using the patient’s height and weight) and ranges from 75 to 200 mg per square metre, once a day. The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temomedac is being used alone or with other treatments, and how the patient responds to treatment.

Temomedac capsules should be taken whole without food. Patients may also need to take medicines to prevent vomiting before taking Temomedac.

For full details, see the summary of product characteristics (also part of the EPAR).

How does Temomedac work?

The active substance in Temomedac, temozolomide, belongs to a group of cancer medicines called alkylating agents. In the body, temozolomide is converted to another compound called MTIC. MTIC binds to the DNA of cells while they are reproducing, which stops cell division. As a result, the cancer cells cannot divide, slowing down the growth of tumours.

How has Temomedac been studied?

Because Temomedac is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefit and risk of Temomedac?

Because Temomedac is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.

Why has Temomedac been approved?

The CHMP concluded that, in accordance with EU requirements, Temomedac has been shown to have comparable quality and to be bioequivalent to Temodal. Therefore, the CHMP’s view was that, as for Temodal, the benefit outweighs the identified risk. The Committee recommended that Temomedac be given marketing authorisation.

Other information about Temomedac:

The European Commission granted a marketing authorisation valid throughout the EU for Temomedac on 25 January 2010.

For more information about treatment with Temomedac, read the Package Leaflet (also part of the EPAR).

Temomedac : EPAR - Summary for the public

Product information

Temomedac : EPAR - Product Information

Temomedac : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Temomedac
• 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

Temomedac hard capsules is indicated for the 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.

Authorisation details

• EMA product number:
  EMEA/H/C/001124
• 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:
  medac Gesellschaft für klinische Spezialpräparate mbH

  Theaterstrasse 6; 22880 Wedel; Germany

• Opinion adopted:
  19/11/2009
• Marketing authorisation issued:
  25/01/2010
• Revision:
  15

Assessment history

Changes since initial authorisation of medicine

Temomedac : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

CHMP summary of positive opinion for Temomedac

AdoptedReference Number: EMEA/CHMP/567028/2009