Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Docetaxel Kabi   

   This product is authorised under a different brandname in the EU in the folowing languages:
   - Docetaksel Kabi (SL)
Auth. number : EU/1/12/770
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 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 over express 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.
Marketing Authorisation Holder: Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, 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
25/05/2012 Centralised - Authorisation EMEA/H/C/2325 (2012)3453 of 22/05/2012
31/10/2012 Centralised - Variation EMEA/H/C/2325/II/2 (2012)7871 of 29/10/2012
29/05/2013 Centralised - Variation EMEA/H/C/2325/IB/5
Updated with Decision(2014)3531 of 22/05/2014
17/10/2013 Centralised - Variation EMEA/H/C/2325/IB/6
Updated with Decision(2014)3531 of 22/05/2014
19/03/2014 Centralised - Variation EMEA/H/C/2325/IB/7
Updated with Decision(2014)3531 of 22/05/2014
27/05/2014 Centralised - Yearly update (2014)3531 of 22/05/2014
17/07/2014 Centralised - Variation EMEA/H/C/2325/IB/9
Updated with Decision(2015)4698 of 03/07/2015
07/07/2015 Centralised - Yearly update (2015)4698 of 03/07/2015
15/12/2015 Centralised - Variation EMEA/H/C/2325/IB/12
Updated with Decision(2016)8660 of 12/12/2016
15/12/2016 Centralised - Yearly update (2016)8660 of 12/12/2016
27/02/2017 Centralised - Renewal EMEA/H/C/2325/R/15 (2017) 1409 of 23/02/2017
06/06/2017 Corrigendum (2017) 1409 of 23/02/2017
01/08/2017 Centralised - Variation EMEA/H/C/2325/IB/16