Docetaxel Kabi

docetaxel

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This is a summary of the European public assessment report (EPAR) for Docetaxel Kabi. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Docetaxel Kabi.

What is Docetaxel Kabi?

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

Docetaxel Kabi is a ‘generic medicine’. This means that Docetaxel Kabi is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Taxotere.

What is Docetaxel Kabi 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 anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the 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 their cancer;
  • 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 yet received any treatment for their cancer. Docetaxel Kabi is used with cisplatin and 5-fluorouracil (other anticancer medicines);
  • head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread). Docetaxel Kabi is used with cisplatin and 5-fluorouracil.

For full details, see the summary of product characteristics (also part of the EPAR).

The medicine can only be obtained with a prescription.

How is Docetaxel Kabi used?

Docetaxel Kabi should be used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.

Docetaxel Kabi is given as a one-hour infusion every three weeks. The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated. Docetaxel Kabi is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3). An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Docetaxel Kabi infusion. For more information, see the summary of product characteristics.

How does Docetaxel Kabi work?

The active substance in Docetaxel Kabi, docetaxel, belongs to the group of anticancer medicines known as the taxanes. Docetaxel blocks the ability of cells to destroy the internal ‘skeleton’ that allows them to divide and multiply. With the skeleton still in place, the cells cannot divide and they eventually die. Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.

How has Docetaxel Kabi been studied?

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

What are the benefits and risks of Docetaxel Kabi?

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

Why has Docetaxel Kabi been approved?

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

Other information about Docetaxel Kabi

The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Kabi on 22 May 2012.

For more information about treatment with Docetaxel Kabi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Docetaxel Kabi : EPAR - Summary for the public BG = bălgarski 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public ES = español 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public CS = čeština 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public DA = dansk 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public DE = Deutsch 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public ET = eesti keel 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public EL = elliniká 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public EN = English 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public FR = français 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public IT = italiano 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public LV = latviešu valoda 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public LT = lietuvių kalba 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public HU = magyar 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public MT = Malti 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public NL = Nederlands 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public PL = polski 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public PT = português 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public RO = română 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public SK = slovenčina 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public SL = slovenščina 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public FI = suomi 18/06/2012  
Docetaxel Kabi : EPAR - Summary for the public SV = svenska 18/06/2012  

This EPAR was last updated on 25/01/2016 .

Authorisation details

Product details

Product details for Docetaxel Kabi
NameDocetaxel Kabi
Agency product numberEMEA/H/C/002325
Active substance

docetaxel

International non-proprietary name (INN) or common name

docetaxel

Therapeutic area Carcinoma, Non-Small-Cell LungProstatic NeoplasmsHead and Neck NeoplasmsAdenocarcinomaBreast Neoplasms
Anatomical therapeutic chemical (ATC) code L01CD02
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Docetaxel Kabi
Marketing-authorisation holder

Fresenius Kabi Oncology Plc

Revision6
Date of issue of marketing authorisation valid throughout the European Union22/05/2012

Contact address:

Fresenius Kabi Oncology Plc
Lion Court
Farnham Road
Bordon
Hampshire
GU35 0NF
United Kingdom

Product information

Product information

15/12/2015  Docetaxel Kabi -EMEA/H/C/002325 -IB/0012

Name Language First published Last updated
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016
Docetaxel Kabi : EPAR - Product Information SV = svenska 18/06/2012 25/01/2016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012
Docetaxel Kabi : EPAR - All Authorised presentations SV = svenska 18/06/2012 27/11/2012

Pharmacotherapeutic group

Antineoplastic Agents

Therapeutic indication

Breast cancer

Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:

  • operable node-positive breast cancer;
  • operable node-negative breast cancer.

For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.

Docetaxel Kabi in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.

Docetaxel Kabi monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.

Docetaxel Kabi in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.

Docetaxel Kabi in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

Non-small-cell lung cancer

Docetaxel Kabi is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.

Docetaxel Kabi in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.

Prostate cancer

Docetaxel Kabi in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

Gastric adenocarcinoma

Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

Head and neck cancer

Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Docetaxel Kabi : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 27/11/2012 25/01/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Docetaxel Kabi : EPAR - Public assessment report SV = svenska 18/06/2012  
CHMP summary of positive opinion for Docetaxel Kabi SV = svenska 16/03/2012  

Authorised

This medicine is approved for use in the European Union

More information on Docetaxel Kabi