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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Invented name:||Docetaxel Kabi This product is authorized under a different brandname in the EU in the folowing languages: - Docetaksel Kabi (SL)|
|Auth. number :||EU/1/12/770|
|ATC:||Anatomical main group: L - Antineoplastic and immunomodulating agents|
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01C - Plant alkaloids and other natural products
Chemical subgroup: L01CD - Taxanes
Chemical substance: L01CD02 - Docetaxel
(See WHO ATC Index)
Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
- operable nodepositive breast cancer
- operable nodenegative 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 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.
Nonsmall cell lung cancer
Docetaxel Kabi is indicated for the treatment of patients with locally advanced or metastatic nonsmall 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 nonsmall cell lung cancer, in patients who have not previously received chemotherapy for this condition.
Docetaxel Kabi in combination with pr
|Marketing Authorisation Holder:||Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register.
|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|
|17/10/2013||Centralised - Variation||EMEA/H/C/2325/IB/6|