PLEASE NOTE: MEDICINAL PRODUCT IS 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 fail. It can be used with cisplatin (another type of anticancer medicine) on patients who have not received previous cancer treatment;
- prostate cancer, when the tumor does not respond to hormonal 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 - Docetaxel used?
Docetaxel Teva Pharma should be used in wards specializing in the administration of chemotherapy (using cancer drugs) 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 drugs depend on the type of cancer to be 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. For more information, see the summary of product characteristics.
How does Docetaxel Teva Pharma - Docetaxel work?
The active substance in Docetaxel Teva Pharma, docetaxel, belongs to the group of anticancer medicines known as the taxanes. Docetaxel blocks the cells' ability to destroy the internal "skeleton" that allows them to divide and multiply. In the presence of the skeleton the cells cannot divide and end up dying. Docetaxel also compromises non-tumor cells, such as blood cells, and this 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 the Docetaxel Teva Pharma solution has qualities comparable to those of Taxotere. No further studies were necessary 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?
Because Docetaxel Teva Pharma is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
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 proved to be comparable to Taxotere. Therefore it is the opinion of the CHMP that, as in the case of Taxotere, the benefits outweigh the identified risks. The Committee recommended the granting of a marketing authorization for Docetaxel Teva Pharma.
More information on Docetaxel Teva Pharma - Docetaxel
On January 21, 2011, the European Commission granted Teva Pharma BV 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.
