Docetaxel Zentiva (previously Docetaxel Winthrop)
Withdrawn
This medicine's authorisation has been withdrawn
docetaxel
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 25 April 2022, the European Commission withdrew the marketing authorisation for Docetaxel Zentiva (docetaxel) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Zentiva, k.s., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Docetaxel Zentiva was granted marketing authorisation in the EU on 20 April 2007 for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2011. Docetaxel Zentiva is identical to Taxotere, which is authorised in the EU to treat breast cancer, nonsmall cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer.
The European Public Assessment Report (EPAR) for Docetaxel Zentiva is updated to indicate that the marketing authorisation is no longer valid.
Product information
25/04/2022
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).
Product details
- Name of medicine
- Docetaxel Zentiva (previously Docetaxel Winthrop)
- Active substance
- docetaxel
- International non-proprietary name (INN) or common name
- docetaxel
- Therapeutic area (MeSH)
- Head and Neck Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Adenocarcinoma
- Prostatic Neoplasms
- Stomach Neoplasms
- Breast Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L01CD02
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic 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.
News on Docetaxel Zentiva (previously Docetaxel Winthrop)
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