Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Spain
Naveruclif 5 mg/ml powder for dispersion for infusion.
| Pharmaceutical Form |
|---|
|
Powder for dispersion for infusion (powder for infusion). The reconstituted dispersion has a pH of 6-7.5 and an osmolality of 300-380 mOsm/kg. White to yellow coloured powder or lyophilized cake. |
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 | Description | |
|---|---|---|
| Paclitaxel |
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 |
|---|
|
Albumin (human) (containing sodium caprylate and N-acetyl-L-tryptophan). |
50 ml vial (type 1 glass) with a stopper (bromobutyl rubber), with an overseal (aluminium), containing 100 mg of paclitaxel formulated as albumin bound nanoparticles.
Pack size of one vial.
Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Spain
EU/1/23/1778/001
| Drug | Countries | |
|---|---|---|
| NAVERUCLIF | Austria, Estonia, France, Croatia, Lithuania |
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