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.
Docetaxel Mylan : EPAR - Summary for the public (PDF/526.06 KB)
First published: 17/02/2012
Last updated: 12/03/2015
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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.
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01/02/2015 Docetaxel Mylan - EMEA/H/C/002317 - IB/0006
- 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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Treatment of breast cancer, special forms of lung cancer (non-small-cell lung cancer), prostate cancer, gastric cancer, or head and neck cancer.