Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Abraxane 5 mg/ml powder for dispersion for infusion.
| Pharmaceutical Form |
|---|
|
Powder for dispersion for infusion. The reconstituted dispersion has a pH of 6-7.5 and an osmolality of 300-360 mOsm/kg. The powder is white to yellow. |
Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles.
After reconstitution, each ml of dispersion contains 5 mg of paclitaxel formulated as albumin bound nanoparticles.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Paclitaxel is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilises microtubules by preventing depolymerisation. This stability results in the inhibition of the normal dynamic reorganisation of the microtubule network that is essential for vital interphase and mitotic cellular functions. |
| List of Excipients |
|---|
|
Human albumin solution (containing sodium caprylate and N-acetyl-L-tryptophan). |
50 ml vial (type 1 glass) with a stopper (butyl rubber), with an overseal (aluminium), containing 100 mg of paclitaxel formulated as albumin bound nanoparticles.
Pack size of one vial.
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
EU/1/07/428/001
Date of first authorisation: 11 January 2008
Date of latest renewal: 14 January 2013
| Drug | Countries | |
|---|---|---|
| ABRAXANE | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States, South Africa |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.