Docetaxel Zentiva (previously Docetaxel Winthrop)
docetaxel
Table of contents
Overview
The marketing authorisation for Docetaxel Zentiva has been withdrawn at the request of the marketing-authorisation holder.
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Docetaxel Zentiva : EPAR - Medicine overview (PDF/702.42 KB)
First published: 18/01/2009
Last updated: 20/05/2022
EMA/543296/2019 -
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Docetaxel Zentiva : EPAR - Risk-management-plan summary (PDF/582.71 KB)
First published: 20/12/2019
Last updated: 20/05/2022
Authorisation details
| Product details | |
|---|---|
| Name |
Docetaxel Zentiva (previously Docetaxel Winthrop)
|
| Agency product number |
EMEA/H/C/000808
|
| Active substance |
docetaxel
|
| International non-proprietary name (INN) or common name |
docetaxel
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
L01CD02
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Zentiva k.s.
|
| Revision |
30
|
| Date of issue of marketing authorisation valid throughout the European Union |
20/04/2007
|
| Contact address |
U kabelovny 130 |
Product information
25/04/2022 Docetaxel Zentiva (previously Docetaxel Winthrop) - EMEA/H/C/000808 -
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
Docetaxel Winthrop 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 Winthrop 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 Winthrop 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 Winthrop in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.
Docetaxel Winthrop 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 Winthrop is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.
Docetaxel Winthrop 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 Winthrop in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer.
Gastric adenocarcinoma
Docetaxel Winthrop 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 Winthrop 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.