Ateromixol 20 mg for what it is for

DOCETAXEL KABI 20 mg / 1 ml concentrate for solution for infusion

Fresenius

traditional herbal registrations
Active ingredientAddictive drugPsychotropic
DocetaxelNoNo
Submission statusDelivery through a (public) pharmacy
Prescription StatusMedicines for dispensing without a doctor's prescription
Pharmacological groupHerbal alkaloids and other natural remedies

All information

What is it?

Docetaxel Kabi is a medicine that contains the active substance docetaxel. It is available as a concentrate that is made up into a solution for infusion (drip into a vein).

Docetaxel Kabi is a 'generic'. This means that Docetaxel Kabi is similar to a 'reference medicine' already authorized in the European Union (EU) called Taxotere. For more information on generics, see the question and answer document here.

What is it used for?

Docetaxel Kabi is used to treat the following types of cancer:

  • Breast cancer. Docetaxel Kabi can be used on its own after other treatments have failed. It can also be used with other anti-cancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received treatment for cancer or after other treatments have failed, depending on the type and stage of breast cancer being treated;
  • non-small cell lung cancer. Docetaxel Kabi 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 cancer;

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  • Prostate cancer, when the cancer does not respond to hormonal treatment. Docetaxel Kabi is used with prednisone or prednisolone (anti-inflammatory medicines);
  • Gastric adenocarcinoma (a type of stomach cancer) in patients who have not received any treatment for cancer. Docetaxel Kabi is used with cisplatin and 5-fluorouracil (other anticancer medicines);

Head and neck cancer in patients whose cancer has advanced locally (i.e., has grown without spreading). Docetaxel Kabi is used together with cisplatin and 5-fluorouracil.

Further details can be found in the summary of product characteristics (also part of the EPAR).

The medicine can only be obtained with a prescription.

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How is it used?

Docetaxel Kabi should only be used in facilities that specialize in chemotherapy (use of medicines to treat cancer) and only under the supervision of a doctor who has experience in chemotherapy.

Docetaxel Kabi is given as a one-hour infusion every three weeks. The dose, duration of treatment and use with other medicines will depend on the type of cancer being treated. Docetaxel Kabi is only used when the neutrophil count (the amount of a type of white blood cell) is normal (at least 1,500 cells / mm3). An anti-inflammatory drug such as dexamethasone should also be given to the patient; this should be started the day before the Docetaxel Kabi infusion. Refer to the Summary of Product Characteristics for more information.

How does it work?

The active substance in Docetaxel Kabi, docetaxel, belongs to a group of cancer medicines called taxanes. Docetaxel inhibits the ability of cells to destroy the internal “skeleton” and thus robs them of the prerequisites for cell division and reproduction. If the skeleton is intact, the cells cannot divide and eventually die. Docetaxel not only affects cancer cells, but also, for example, blood cells, which can lead to side effects.

How was it researched?

The company provided data from the published literature on docetaxel. The company also demonstrated that Docetaxel Kabi solution for infusion was comparable in quality to Taxotere. No additional studies were needed as Docetaxel Kabi is a generic medicine given by infusion and contains the same active substance as the reference medicine, Taxotere.

What benefits has it shown in the studies?

Because Docetaxel Kabi is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Docetaxel Kabi

EMA / 349061/2012

Why was it allowed?

The CHMP concluded that Docetaxel Kabi has been shown to be comparable to Taxotere in accordance with EU requirements. Therefore, the CHMP's view was that, as for Taxotere, the benefit outweighs the identified risk and recommended that Docetaxel Kabi be given marketing authorization.

More information about Docetaxel Kabi

On May 22, 2012, the European Commission granted Docetaxel Kabi marketing authorization across the European Union.

The full EPAR for Docetaxel Kabi can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Docetaxel Kabi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency's website.

This summary was last updated in 04-2012.

Docetaxel Kabi

EMA / 349061/2012

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