Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, Barcelona, 08039, Spain
Cabazitaxel Accord 20 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear colourless to pale yellow or brownish yellow solution. |
Each ml of concentrate contains 20 mg cabazitaxel.
Each vial of 3 ml of concentrate contains 60 mg cabazitaxel.
Excipient with known effect:
The finished product contains 395 mg/ml of ethanol anhydrous, thus each 3 ml vial contains 1,185 mg ethanol anhydrous.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Cabazitaxel |
Cabazitaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells. Cabazitaxel binds to tubulin and promotes the assembly of tubulin into microtubules while simultaneously inhibiting their disassembly. |
| List of Excipients |
|---|
|
Polysorbate 80 |
3 ml of concentrate in a 6 ml clear tubular glass vial (type I) closed with a 20 mm grey siliconized rubber closure (type I) with teflon film on plug surface and sealed by an aluminium cap covered with a violet plastic flip-off cap.
Each carton contains one single use vial.
Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, Barcelona, 08039, Spain
EU/1/20/1448/001
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