Docetaxel Teva Pharma
docetaxel
Table of contents
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.
Authorisation details
| Product details | |
|---|---|
| Name |
Docetaxel Teva Pharma
|
| Agency product number |
EMEA/H/C/002032
|
| Active substance |
docetaxel
|
| International non-proprietary name (INN) or common name |
docetaxel
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
L01CD02
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Teva Pharma B.V.
|
| Revision |
6
|
| Date of issue of marketing authorisation valid throughout the European Union |
21/01/2011
|
| Contact address | |
Product information
21/01/2014 Docetaxel Teva Pharma - EMEA/H/C/002032 - IB/7/G
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Antineoplastic agents
Therapeutic 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.