Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Taxespira   
Auth. number : EU/1/15/1017
Active substance : docetaxel
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01C - Plant alkaloids and other natural products
Chemical subgroup: L01CD - Taxanes
Chemical substance: L01CD02 - Docetaxel
(See WHO ATC Index)
Indication: Breast cancer
Docetaxel Hospira UK Limited 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 (see section 5.1).
Docetaxel Hospira UK Limited 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 Hospira UK Limited 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 Hospira UK Limited in 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.
Docetaxel Hospira UK Limited 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 Hospira UK Limited is indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer after failure of prior chemotherapy.
Docetaxel Hospira UK Limited 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 Hospira UK Limited in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

Gastric adenocarcinoma
Docetaxel Hospira UK Limited 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 Hospira UK Limited 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.
Marketing Authorisation Holder: Hospira UK Limited
Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
01/09/2015 Centralised - Authorisation EMEA/H/C/3925 (2015)6109 of 28/08/2015
13/11/2015 Centralised - Variation EMEA/H/C/3925/IAin/1/G
Updated with Decision(2016)7417 of 11/11/2016
28/01/2016 Centralised - Variation EMEA/H/C/3925/IB/4
Updated with Decision(2016)7417 of 11/11/2016
17/03/2016 Centralised - Variation EMEA/H/C/3925/II/3
Updated with Decision(2016)7417 of 11/11/2016
17/06/2016 Centralised - Notification EMEA/H/C/3925/N/6
Updated with Decision(2016)7417 of 11/11/2016
15/11/2016 Centralised - Yearly update (2016)7417 of 11/11/2016
16/02/2017 Centralised - Notification EMEA/H/C/3925/N/7
01/08/2017 Centralised - Variation EMEA/H/C/3925/IB/8
16/11/2017 Centralised - Notification EMEA/H/C/3925/N/9