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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMEA/H/C/002198

EPAR summary for the public

Temozolomide Sun

temozolomide

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

What is Temozolomide Sun?

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

Temozolomide Sun is a 'generic medicine'. This means that Temozolomide Sun is similar to a 'reference medicine' already authorised in the European Union (EU) called Temodal. For more information on generic medicines, see the question-and-answer document here.

What is Temozolomide Sun used for?

Temozolomide Sun is an anticancer medicine. It 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). Temozolomide Sun 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. Temozolomide Sun is used on its own in these patients.

The medicine can only be obtained with a prescription.

7 Westferry Circus • Canary Wharf • London E14 4HB • United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail info@ema.europa.eu Website www.ema.europa.eu

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.

How is Temozolomide Sun used?

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

The dose of Temozolomide Sun 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 Temozolomide Sun is being used alone or with other treatments, and how the patient responds to treatment. Temozolomide Sun should be taken without food.

Patients may also need to take medicines to prevent vomiting before taking Temozolomide Sun. Temozolomide Sun should be used with caution in patients with severe liver problems or with kidney problems.

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

How does Temozolomide Sun work?

The active substance in Temozolomide Sun, temozolomide, belongs to a group of anticancer 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 Temozolomide Sun been studied?

Because Temozolomide Sun is a generic medicine, studies in patients 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 benefits and risks of Temozolomide Sun?

Because Temozolomide Sun is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why has Temozolomide Sun been approved?

The CHMP concluded that, in accordance with EU requirements, Temozolomide Sun 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 Temozolomide Sun be given marketing authorisation.

Other information about Temozolomide Sun

The European Commission granted a marketing authorisation valid throughout the European Union for Temozolomide Sun on 13 July 2011.

The full EPAR for Temozolomide Sun can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Temozolomide Sun, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency's website.

Temozolomide Sun

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