Taxotere 20mg/1ml concentrate for solution for infusion (2012)
Active ingredients: Docetaxel
Product Name and Form
TAXOTERE 20 mg/1 ml concentrate for solution for infusion.
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a pale yellow to brownish-yellow solution.
Qualitative and Quantitative Composition
Each ml of concentrate contains 20 mg docetaxel (as trihydrate).
One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Excipient with known effect: Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
For the full list of excipients, see section 6.1.
Polysorbate 80
Ethanol anhydrous
Citric acid
Pack sizes and Marketing
7 ml clear glass (type I) vial with a green aluminium seal and a green plastic flip-off cap containing 1 ml of concentrate.
Each box contains one vial.
Not all pack sizes may be marketed.
Aventis Pharma S.A.
20 avenue Raymond Aron
92165 Antony Cedex
France
Date of first authorisation: 27 November 1995
Date of latest renewal: 27 November 2005
EU/1/95/002/003