Taxespira (previously Docetaxel Hospira UK Limited )
docetaxel
Table of contents
Overview
The marketing authorisation for Taxespira has been withdrawn at the request of the marketing authorisation holder.
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Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Summary for the public (PDF/1.12 MB)
First published: 17/09/2015
Last updated: 15/10/2019
EMA/471475/2015 -
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Taxespira (previously Docetaxel Hospira UK Limited) : EPAR - Risk-management-plan summary (PDF/1.08 MB)
First published: 17/09/2015
Last updated: 15/10/2019
Authorisation details
| Product details | |
|---|---|
| Name |
Taxespira (previously Docetaxel Hospira UK Limited )
|
| Agency product number |
EMEA/H/C/003925
|
| Active substance |
docetaxel trihydrate
|
| International non-proprietary name (INN) or common name |
docetaxel
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
L01CD02
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Hospira UK Limited
|
| Revision |
8
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| Date of issue of marketing authorisation valid throughout the European Union |
28/08/2015
|
| Contact address |
Horizon, Honey Lane
Hurley, Maidenhead, SL6 6RJ United Kingdom |
Product information
30/10/2018 Taxespira (previously Docetaxel Hospira UK Limited ) - EMEA/H/C/003925 - IB/0011
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.