PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED
What is Docetaxel Mylan?
Docetaxel Mylan is a medicine that contains the active substance docetaxel. It is available as a concentrate to make a solution for infusion (drip into a vein).
Docetaxel Mylan is a 'generic medicine'. This means that Docetaxel Mylan is similar to a 'reference medicine' already authorized in the European Union (EU) called Taxotere. For more information on generic medicines, please see the questions and answers by clicking here.
What is Docetaxel Mylan used for?
Docetaxel Mylan is used to treat the following types of cancer:
- breast cancer. Docetaxel Mylan 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 Mylan 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 Mylan 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 Mylan used in combination with cisplatin and 5-fluorouracil (other anticancer drugs);
- head and neck cancer in patients with advanced cancer (which has already started to spread). Docetaxel Mylan is used in combination with cisplatin and 5-fluorouracil.
For more information, see the Summary of Product Characteristics (included in the EPAR). The medicine can only be obtained with a prescription.
How is Docetaxel Mylan used?
Docetaxel Mylan is used in wards specializing in the administration of chemotherapy (medicines to treat cancer) under the supervision of a physician qualified in the use of chemotherapy.
Docetaxel Mylan 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 Mylan should only be used when it is used. 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 drug) the day before Docetaxel Mylan is given. infusion For more information, see the Summary of Product Characteristics.
How does Docetaxel Mylan work?
The active substance in Docetaxel Mylan, 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 (for example, blood cells) causing possible side effects.
How has Docetaxel Mylan been studied?
The company presented data from the scientific literature on docetaxel. The company also showed that Docetaxel Mylan's solution has comparable qualities to Taxotere's. No further studies were needed because Docetaxel Mylan 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 Mylan?
Since Docetaxel Mylan is a generic medicine, the benefits and risks are assumed to be the same as the reference medicine.
Why has Docetaxel Mylan been approved?
The CHMP concluded that, in accordance with EU requirements, Docetaxel Mylan was shown to be comparable to Taxotere. Therefore it is the CHMP's view that, as in the case of Taxotere, the benefits outweigh the identified risks. The Committee recommended the release of the marketing authorization for Docetaxel Mylan.
More information about Docetaxel Mylan
On January 31, 2012, the European Commission issued a "Marketing Authorization" for Docetaxel Mylan, valid throughout the European Union.
For more information about Docetaxel Mylan therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 12-2011.
The information on Docetaxel Mylan 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.
