Overview
The marketing authorisation for Docetaxel Teva Pharma has lapsed because it ceased to be marketed in the European Union more than three years ago and an exemption granted by the European Commission has expired.
Docetaxel Teva Pharma : EPAR - Summary for the public
Product information
Docetaxel Teva Pharma : EPAR - Product Information
Latest procedure affecting product information: IB/7/G
21/01/2014
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).
Docetaxel Teva Pharma : EPAR - All Authorised presentations
Product details
- Name of medicine
- Docetaxel Teva Pharma
- Active substance
- docetaxel
- International non-proprietary name (INN) or common name
- docetaxel
- Therapeutic area (MeSH)
- Carcinoma, Non-Small-Cell Lung
- Breast Neoplasms
- Prostatic Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L01CD02
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Breast cancer
Docetaxel Teva Pharma 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.
Non-small-cell lung cancer
Docetaxel Teva Pharma is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.
Docetaxel Teva Pharma 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 Teva Pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Assessment history
Docetaxel Teva Pharma : EPAR - Procedural steps taken and scientific information after authorisation