Docetaxel Accord

docetaxel

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This is a summary of the European public assessment report (EPAR) for Docetaxel Accord. 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 Accord.

What is Docetaxel Accord?

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

What is Docetaxel Accord used for?

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

  • breast cancer. Docetaxel Accord 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 Accord 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 Accord 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 Accord 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 Accord 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 Accord used?

Docetaxel Accord 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 Accord 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 Accord 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 Accord infusion. For more information, see the summary of product characteristics.

How does Docetaxel Accord work?

The active substance in Docetaxel Accord, 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 Accord been studied?

The company provided data from published literature on docetaxel. The company also showed that the Docetaxel Accord solution for infusion has comparable quality to that of Taxotere. No additional studies were needed as Docetaxel Accord 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 Accord?

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

Why has Docetaxel Accord been approved?

The CHMP concluded that, in accordance with EU requirements, Docetaxel Accord 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 Accord be given marketing authorisation.

Other information about Docetaxel Accord

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

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

Name Language First published Last updated
Docetaxel Accord : EPAR - Summary for the public BG = bălgarski 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public ES = español 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public CS = čeština 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public DA = dansk 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public DE = Deutsch 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public ET = eesti keel 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public EL = elliniká 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public EN = English 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public FR = français 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public IT = italiano 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public LV = latviešu valoda 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public LT = lietuvių kalba 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public HU = magyar 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public MT = Malti 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public NL = Nederlands 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public PL = polski 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public PT = português 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public RO = română 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public SK = slovenčina 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public SL = slovenščina 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public FI = suomi 2012-06-11  
Docetaxel Accord : EPAR - Summary for the public SV = svenska 2012-06-11  

This EPAR was last updated on 05/02/2018 .

Authorisation details

Product details

Product details for Docetaxel Accord
NameDocetaxel Accord
Agency product numberEMEA/H/C/002539
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 Accord
Marketing-authorisation holder

Accord Healthcare Ltd

Revision9
Date of issue of marketing authorisation valid throughout the European Union22/05/2012

Contact address:

Accord Healthcare Ltd
Ground Floor
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom

Product information

Product information

21/12/2017  Docetaxel Accord -EMEA/H/C/002539 -IB/0034/G

Name Language First published Last updated
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05
Docetaxel Accord : EPAR - Product Information SV = svenska 2012-06-11 2018-02-05

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 Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  
Docetaxel Accord : EPAR - All Authorised presentations SV = svenska 2012-06-11  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Breast cancer

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

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

Gastric adenocarcinoma

Docetaxel Accord 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 Accord 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 Accord : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2012-10-11 2018-02-05

Initial marketing-authorisation documents

Name Language First published Last updated
Docetaxel Accord : EPAR - Public assessment report SV = svenska 2012-06-11  
CHMP summary of positive opinion for Docetaxel Accord SV = svenska 2012-03-16  

Authorised

This medicine is approved for use in the European Union

More information on Docetaxel Accord