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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.

Pharmaceutical form

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.

Chemical substance
Description
Docetaxel

Docetaxel is an antineoplastic agent which acts by promoting the assembly of tubulin into stable microtubules and inhibits their disassembly which leads to a marked decrease of free tubulin.

List of excipients

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.

Marketing authorization holder
Authorization dates

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

Marketing authorization number:

EU/1/95/002/003