PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED
What is Docetaxel Teva Pharma - Docetaxel?
Docetaxel Teva Pharma is a medicine that contains the active substance docetaxel. It is available as a concentrate and solvent for solution for infusion (drip into a vein). Docetaxel Teva Pharma is a 'generic medicine'. This means that Docetaxel Teva Pharma is similar to a 'reference medicine' already authorized in the European Union (EU) called Taxotere.
What is Docetaxel Teva Pharma - Docetaxel used for?
Docetaxel Teva Pharma is used to treat the following types of cancer:
- breast cancer. Docetaxel Teva Pharma monotherapy is indicated after the failure of other therapies;
- non-small cell lung cancer. Docetaxel Teva Pharma can be used on its own after other therapies have failed. It can be used with cisplatin (another type of cancer medicine) in patients who have not received previous cancer treatments;
- prostate cancer, when the cancer does not respond to hormone treatment. Docetaxel Teva Pharma is used with prednisone or prednisolone (anti-inflammatory medicines);
The medicine can only be obtained with a prescription.
How is Docetaxel Teva Pharma used - Docetaxel?
Docetaxel Teva Pharma is used in wards specializing in the administration of chemotherapy (which use drugs to treat cancer) under the supervision of a physician qualified in the use of chemotherapy. Docetaxel Teva Pharma 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 Pharma is used only when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells / mm3). The patient should also be given Dexamethasone (an anti-inflammatory medicine) the day before the infusion of Docetaxel Teva Pharma See the Summary of Product Characteristics for more information.
How does Docetaxel Teva Pharma - Docetaxel work?
The active substance in Docetaxel Teva Pharma, docetaxel, belongs to the group of anticancer medicines known as taxanes. Docetaxel blocks the ability of cells to destroy the internal "skeleton" that allows them to divide and multiply. In the presence of the skeleton, cells cannot divide and end up dying. Docetaxel also affects non-cancer cells, such as blood cells, which can cause side effects.
How has Docetaxel Teva Pharma - Docetaxel been studied?
The company presented data on docetaxel from the scientific literature. The company also showed that Docetaxel Teva Pharma's solution has comparable qualities to Taxotere's. No further studies were needed because Docetaxel Teva Pharma is a generic medicine, given by infusion and containing the same active substance as the reference medicine, Taxotere.
What are the benefits and risks of Docetaxel Teva Pharma - Docetaxel?
Since Docetaxel Teva Pharma is a generic medicine, the benefits and risks are assumed to be the same as the reference medicine.
Why has Docetaxel Teva Pharma - Docetaxel been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU legislation, Docetaxel Teva Pharma has been shown to be comparable to Taxotere. Therefore, it is the CHMP's view that, as in the case of Taxotere, the benefits outweigh the risks identified. The Committee recommended that Docetaxel Teva Pharma be given marketing authorization.
More information about Docetaxel Teva Pharma - Docetaxel
On 21 January 2011, the European Commission released Teva Pharma B.V. a "Marketing Authorization" for Docetaxel Teva Pharma, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed. Last update of this summary: 11- 2010.
The information on Docetaxel Teva Pharma - Docetaxel 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.
