What is Docetaxel Teva?
Docetaxel Teva is a concentrate and solvent that are made up into a solution for infusion (drip into a vein). Contains the active ingredient docetaxel.
Docetaxel Teva is a 'generic medicine', which means that Docetaxel Teva is similar to a 'reference medicine' already authorized in the European Union (EU) called Taxotere.
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 in combination with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not received previous therapy for their condition or after other treatments have failed, depending on the type of breast cancer being treated. and at the stage of progression;
non-small cell lung cancer. Docetaxel Teva can be used on its own after other treatments have failed. It can also be used in combination with cisplatin (another anticancer medicine) in patients who have not previously undergone other treatments for their cancer;
prostate cancer, when the cancer does not respond to hormone treatment. Docetaxel Teva is used in combination with prednisone or prednisolone (anti-inflammatory drugs);
gastric adenocarcinoma (a type of stomach cancer) in patients who have not previously received treatment for their cancer. Docetaxel Teva used in combination with cisplatin and 5-fluorouracil (other anticancer medicines);
head and neck cancer in patients with advanced cancer (which has already started to spread). Docetaxel Teva is used in combination with cisplatin and 5-fluorouracil.
For a detailed description, please refer to the Summary of Product Characteristics, enclosed with the EPAR.
The medicine can only be obtained with a prescription.
How is Docetaxel Teva used?
The use of Docetaxel Teva must be confined to wards specialized in chemotherapy and its administration must be carried out under the supervision of a physician qualified to administer anticancer chemotherapy.
Docetaxel Teva is given as a one-hour infusion every three weeks. The dose, duration of treatment and its use in combination with other medicines depend on the type of cancer being treated. Docetaxel Teva should only be used when the neutrophil count (a type of white blood cell) is at least 1,500 cells / mm3 For prostate cancer, treatment with dexamethasone (an anti-inflammatory drug) is required one day before starting therapy; for other types of cancer one day before and two days after treatment. For more information, see the summary of the product characteristics.
How does Docetaxel Teva work?
The active substance in Docetaxel Teva, docetaxel, belongs to the group of anticancer medicines known as taxanes. Docetaxel blocks the ability of cells to destroy the internal 'skeleton', which allows them to divide and multiply. In the presence of the skeleton, the cells cannot divide and therefore die. Docetaxel also affects non-cancer cells (for example blood cells) which can cause side effects.
How has Docetaxel Teva been studied?
Since Docetaxel Teva is a generic medicine, the pharmaceutical company presented data already published in the medical literature on docetaxel. No further studies were needed because Docetaxel Teva is a generic medicine, given by infusion and containing the same active substance as the reference medicine, Taxotere. In addition, the company presented studies to show that Docetaxel Teva solution for infusion has comparable qualities to Taxotere.
What are the benefits and risks of Docetaxel Teva?
Since Docetaxel Teva is a generic medicine, the benefits and risks are assumed to be 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 the requirements of the European Union, Docetaxel Teva has been shown to be comparable to Taxotere. Therefore, it is the view of the CHMP that, as in the case of Taxotere, the benefits exceed the identified risks. The Committee recommended that Docetaxel Teva be given marketing authorization.
Why has Docetaxel Teva been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of the European Union, Docetaxel Teva has been shown to be comparable to Taxotere. Therefore, it is the view of the CHMP that, as in the case of Taxotere, the benefits exceed the identified risks. The Committee recommended that Docetaxel Teva be given marketing authorization.
Other information about Docetaxel Teva
On January 26, 2010, the European Commission released Teva Pharma B.V. a "Marketing Authorization" for Docetaxel Teva, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.
For the full version of the Docetaxel Teva EPAR click here.
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 12-2009.
The information on Docetaxel Teva 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.
