Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: Aventis Pharma S.A. 20 avenue Raymond Aron 92165 Antony Cedex France
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. |
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.
| Active Ingredient |
|---|
|
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 |
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
EU/1/95/002/003
Date of first authorisation: 27 November 1995
Date of latest renewal: 27 November 2005
| Drug | Countries | |
|---|---|---|
| TAXOTERE | Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, France, Hong Kong, Ireland, Japan, Lithuania, Mexico, Nigeria, Netherlands, Poland, Tunisia, United States |
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