Docetaxel Teva 80 mg concentrate and solvent for solution forinfusion

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.

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

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 advanced has started to spread. Docetaxel Teva is used with cisplatin and 5-fluorouracil.

See the Summary of Product Characteristics, also part of the EPAR, for full details.

The medicine can only be obtained with a prescription.

Docetaxel Teva should be used in specialised chemotherapy wards and it should only be given under the supervision of a doctor who is qualified in the use of anticancer 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/mm ³.) 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 Summary of Product Characteristics.

The active substance in Docetaxel Teva, docetaxel, belongs to the group of anticancer medicines known as the taxanes. Docetaxel blocks the ability of cells to destroy the internal ?skeleton? that allows them to divide and multiply. With the skeleton still in place, the cells cannot divide and they eventually die. Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.

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.

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

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

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.