What is Temozolomide Sandoz?
Temozolomide Sandoz is a medicine that contains the active substance temozolomide. It is available as capsules (white and green: 5 mg; white and yellow: 20 mg; white and pink: 100 mg; white and blue: 140 mg; white and brown: 180 mg; white: 250 mg).
Temozolomide Sandoz is a 'generic medicine', which means that Temozolomide Sandoz is similar to a 'reference medicine' already authorized in the European Union (EU) called Temodal.
What is Temozolomide Sandoz used for?
Temozolomide Sandoz is an anticancer medicine. It is indicated for the treatment of malignant gliomas (brain tumors) in the following patient groups:
adults recently diagnosed with glioblastoma multiforme (a particularly aggressive type of brain tumor). Temozolomide Hospira is used first with radiation therapy, then alone;
adults and children from three years of age with a malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumor has reappeared or got worse after standard treatment. Temozolomide Hospira is used alone in these patients.
The medicine can only be obtained with a prescription.
How is Temozolomide Sandoz used?
Treatment with Temozolomide Sandoz should be prescribed by a doctor who has experience in the treatment of brain tumors.
The dosage of Temozolomide Sandoz, given once a day, depends on the body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square meter once a day. The dosage and number of doses they depend on the type of cancer being treated, whether the patient has been treated previously, whether Temozolomide Sandoz is used alone or with other therapies, and the patient's response to treatment. Temozolomide Sandoz is taken between meals.
Before being given Temozolomide Sandoz, patients may also need a medicine that prevents vomiting. Temozolomide Sandoz should be used with caution in patients with severe liver or kidney problems.
For complete information, see the Summary of Product Characteristics (also included in the EPAR).
How does Temozolomide Sandoz work?
The active substance in Temozolomide Sandoz, temozolomide, belongs to a group of anticancer medicines called alkylating agents. In the body, temozolomide is converted into another compound called MTIC. MTIC binds to the DNA of cells during the reproductive phase, thereby blocking cell division. As a result, cancer cells cannot reproduce and tumor growth is slowed down.
How has Temozolomide Sandoz been studied?
Since Temozolomide Sandoz is a generic medicine, the studies were limited to evidence designed to show that the medicine 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 Sandoz?
Because Temozolomide Sandoz is a generic medicine and is bioequivalent to the reference medicine, the benefits and risks of the medicine are assumed to be the same as the reference medicine.
Why has Temozolomide Sandoz been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, based on the requirements of EU legislation, Temozolomide Sandoz has been shown to have comparable quality and to be bioequivalent to Temodal. Therefore, the CHMP is of the opinion that, as in the case of Temodal, the benefits outweigh the identified risks. The Committee therefore recommended the granting of marketing authorization for Temozolomide Sandoz.
Other information about Temozolomide Sandoz
On March 15, 2010, the European Commission granted Sandoz Pharmaceutical GmbH a "Marketing Authorization" for Temozolomide Sandoz, valid throughout the European Union. The "Marketing Authorization" is valid for five years and thereafter. period can be renewed.
For the full EPAR version of Temozolomide Sandoz, click here. For more information on therapy with Temozolomide Sandoz, please read the package leaflet (included with the EPAR).
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 01/2010.
The information on Temozolomide Sandoz published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
