Taxespira (previously Docetaxel Hospira UK Limited )

docetaxel

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This is a summary of the European public assessment report (EPAR) for Taxespira. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Taxespira.

For practical information about using Taxespira, patients should read the package leaflet or contact their doctor or pharmacist.

What is Taxespira and what is it used for?

Taxespira is a cancer medicine used to treat the following types of cancer:

  • breast cancer. Taxespira can be used on its own after other treatments have failed. It can also be used with other cancer 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. Taxespira can be used on its own after other treatments have failed. It can also be used with cisplatin (another cancer medicine) in patients who have not yet received any treatment for their cancer;
  • prostate cancer, when the cancer does not respond to hormonal treatment. Taxespira 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. Taxespira is used with cisplatin and 5-fluorouracil (other cancer medicines);
  • head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread). Taxespira is used with cisplatin and 5-fluorouracil.

Taxespira contains the active substance docetaxel and is a ‘generic medicine’. This means that Taxespira is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Taxotere.

How is Taxespira used?

Taxespira is 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.

Taxespira is available as a concentrate for solution for infusion (drip) into a vein and 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. Taxespira 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 Taxespira infusion.

For more information, see the summary of product characteristics.

How does Taxespira work?

The active substance docetaxel, belongs to the group of anticancer medicines known as the taxanes. Docetaxel blocks a stage of cell division, whereby the internal ‘skeleton’ is dismantled to allow the cell to divide. By keeping the skeleton intact 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 Taxespira been studied?

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

What are the benefits and risks of Taxespira?

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

Why is Taxespira approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Taxespira 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 Taxespira be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Taxespira?

A risk management plan has been developed to ensure that Taxespira is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Taxespira, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Taxespira

The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Hospira UK Limited on 28 August 2015. 

The name of the medicine was changed to Taxespira on 12 October 2015.

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

Name Language First published Last updated
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public BG = bălgarski 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public ES = español 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public CS = čeština 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public DA = dansk 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public DE = Deutsch 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public ET = eesti keel 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public EL = elliniká 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public EN = English 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public FR = français 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public IT = italiano 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public LV = latviešu valoda 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public LT = lietuvių kalba 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public HU = magyar 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public MT = Malti 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public NL = Nederlands 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public PL = polski 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public PT = português 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public RO = română 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public SK = slovenčina 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public SL = slovenščina 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public FI = suomi 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public SV = svenska 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public HR = Hrvatski 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public IS = Islenska 2015-09-17 2016-02-02
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public NO = Norsk 2015-09-17 2016-02-02
Name Language First published Last updated
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Risk-management-plan summary (English only) 2015-09-17 2016-02-02

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

Authorisation details

Product details

Product details for Taxespira (previously Docetaxel Hospira UK Limited )
NameTaxespira (previously Docetaxel Hospira UK Limited )
Agency product numberEMEA/H/C/003925
Active substance

docetaxel trihydrate

International non-proprietary name (INN) or common name

docetaxel

Therapeutic area Prostatic NeoplasmsCarcinoma, Non-Small-Cell LungHead and Neck NeoplasmsStomach NeoplasmsBreast 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 Taxespira (previously Docetaxel Hospira UK Limited )
Marketing-authorisation holder

Hospira UK Limited

Revision7
Date of issue of marketing authorisation valid throughout the European Union28/08/2015

Contact address:

Hospira UK Limited
Horizon
Honey Lane
Hurley
Maidenhead
SL6 6RJ
United Kingdom

Product information

Product information

12/01/2018  Taxespira (previously Docetaxel Hospira UK Limited ) -EMEA/H/C/003925 -IB/00010/G

Name Language First published Last updated
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 2018-02-05
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Product Information EN = English 2015-09-17 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
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13
Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - All Authorised presentations EN = English 2015-09-17 2016-04-13

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Breast cancer

Taxespira 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.

Taxespira 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.

Taxespira 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.

Taxespira combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.

Taxespira 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

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

Taxespira 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

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

Gastric adenocarcinoma

Taxespira 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

Taxespira 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

Initial marketing-authorisation documents

Name Language First published Last updated
Docetaxel Hospira UK Limited : EPAR - Public assessment report EN = English 2015-09-17  
CHMP summary of opinion for Docetaxel Hospira UK Limited EN = English 2015-06-26  

Authorised

This medicine is approved for use in the European Union

More information on Docetaxel Hospira