Docetaxel Mylan
docetaxel
Table of contents
Overview
The marketing authorisation for Docetaxel Mylan has lapsed becasue it has not been marketed in the European Union in the three years following the granting of the authorisation.
Authorisation details
| Product details | |
|---|---|
| Name |
Docetaxel Mylan
|
| Agency product number |
EMEA/H/C/002317
|
| Active substance |
docetaxel, anhydrous
|
| 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 |
Mylan S.A.S.
|
| Revision |
6
|
| Date of issue of marketing authorisation valid throughout the European Union |
31/01/2012
|
| Contact address | |
Product information
01/02/2015 Docetaxel Mylan - EMEA/H/C/002317 - IB/0006
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
Treatment of breast cancer, special forms of lung cancer (non-small-cell lung cancer), prostate cancer, gastric cancer, or head and neck cancer.