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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/112747/2011

EMEA/H/C/001107

EPAR summary for the public

Docetaxel Teva

docetaxel

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

What is Docetaxel Teva?

Docetaxel Teva is a concentrate and solvent to be made up into a solution for infusion (drip) into a vein. It contains the active substance docetaxel.

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

What is Docetaxel Teva used for?

Docetaxel Teva is an anticancer medicine. It is used in the following types of cancer:

•    breast cancer. Docetaxel Teva can be used on its own after other treatments have failed. It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;

•    non-small cell lung cancer. Docetaxel Teva can be used on its own after other treatments have failed. It can also be used with cisplatin (another anticancer medicine) in patients who have not yet received any treatment for their cancer;

•    prostate cancer, when the cancer does not respond to hormonal treatment. Docetaxel Teva is used with prednisone or prednisolone (anti-inflammatory medicines);

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•    gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer. Docetaxel Teva is used with cisplatin and 5-fluorouracil (other anticancer medicines);

•    head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread). Docetaxel Teva is used with cisplatin and 5-fluorouracil.

The medicine can only be obtained with a prescription.

How is Docetaxel Teva used?

Docetaxel Teva should be used in wards specialised in chemotherapy (medicines to treat cancer) and it should only be given under the supervision of a doctor who is qualified in the use of cancer chemotherapy.

Docetaxel Teva is given as a one-hour infusion every three weeks. The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated. Docetaxel Teva is only used when the neutrophil count (the level of a type of white blood cell) is normal (at least 1,500 cells/mm³.) Dexamethasone (an anti-inflammatory medicine) should also be given to the patient, starting on the day before the Docetaxel Teva infusion. For more information, see the package leaflet.

How does Docetaxel Teva work?

The active substance in Docetaxel Teva, docetaxel, belongs to the group of anticancer medicines known as the taxanes. Docetaxel blocks a stage of cell division, whereby the internal 'skeleton' is dismantled to allow the cell to divide. By keeping the skeleton intact the cells cannot divide and they eventually die. Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.

How has Docetaxel Teva been studied?

Because Docetaxel Teva is a generic medicine, the company has provided data from the published literature on docetaxel. No additional studies were needed as Docetaxel Teva is given by infusion and contains the same active substance as the reference medicine, Taxotere. In addition, the company presented studies to show that the Docetaxel Teva solution for infusion has comparable quality to that of Taxotere.

What benefit and risk of Docetaxel Teva?

Because Docetaxel Teva is a generic medicine, its benefit and risk are taken as being the same as the reference medicine.

Why has Docetaxel Teva been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Docetaxel Teva has been shown to have comparable quality to Taxotere. Therefore, the CHMP's view was that, as for Taxotere, the benefit outweighs the identified risk. The Committee recommended that Docetaxel Teva be given marketing authorisation.

Other information about Docetaxel Teva

The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Teva on 26 January 2010.

The full EPAR for Docetaxel Teva 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 Docetaxel Teva, 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.

This summary was last updated in 06-2014.

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Docetaxel Teva

EMA/340813/2014