Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-8374 |
| Trade Name | Dose Form | Strength | Identifier |
| Abraxane | Powder for injection | 100 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Celgene Limited P O Box 3035 Wellington | 11/6/2009 | Consent given Approval date: 15/7/2010 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| powder for injection | Active | |
| Paclitaxel 100mg (nanoparticle albumin-bound) | ScinoPharm Taiwan Ltd 1 Nan-Ke 8th Road Shan-Hua Tainan 74144 TAIWAN | |
| Indena SpA Via Don Minzoni 6 Settala Milano 20049 ITALY | ||
| Excipient | ||
| Albumin |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Abraxis BioScience LLC 620 North 51st Avenue Phoenix Arizona 85043 UNITED STATES OF AMERICA |
| Baxter Oncology GmbH Kantstrasse 2 Halle-Westfalen, Westfalen D-33790 GERMANY | |
| Manufacture of Final Dose Form | Abraxis BioScience LLC 620 North 51st Avenue Phoenix Arizona 85043 UNITED STATES OF AMERICA |
| Baxter Oncology GmbH Kantstrasse 2 Halle-Westfalen, Westfalen D-33790 GERMANY | |
| Packing | Abraxis BioScience LLC 620 North 51st Avenue Phoenix Arizona 85043 UNITED STATES OF AMERICA |
| Baxter Oncology GmbH Kantstrasse 2 Halle-Westfalen, Westfalen D-33790 GERMANY | |
| Secondary Packaging | Annex Holdings Pty Ltd t/a Annex Industries 114 Fairbank Road Clayton South VIC 3169 AUSTRALIA |
| Contract Pharmaceutical Services of Australia Pty Ltd 5 Eden Park Drive North Ryde NSW 2113 AUSTRALIA | |
| Healthcare Supply Partners Pty Ltd T/A Healthcare Logistics 7 Dolerite Way Pemulwuy NSW 2145 AUSTRALIA | |
| World Courier Australia Pty Ltd 18 Reid Way Melbourne Airport VIC 3045 AUSTRALIA | |
| NZ Site of Product Release | No site specified |
Packaging
| Package | Contents | Shelf Life |
| Vial, glass, 50 mL Type I 20 mm with chlorobutyl rubber stopper and flip-cap aluminium crimp seal | 1 dose units | 36 months from date of manufacture stored at or below 25°C protect from light 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Should be used immediately but can be stored if required |
| Vial, glass, 50 mL Type I 20 mm with bromobutyl rubber stopper and flip-cap aluminium crimp seal | 1 dose units | 36 months from date of manufacture stored at or below 25°C protect from light 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Should be used immediately but can be stored if required |
Indications
Abraxane is indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy.
Abraxane, in combination with carboplatin, is indicated for the first line treatment of non-small cell lung cancer (NCSLC) in patients who are not candidates for potentially curative surgery and/or radiation.
Abraxane, in combination with gemcitabine, is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 20/2/2023 | Self-Assessable Change Notification | Labelling - G1 (Self assessable); Data sheet - G1 (Self assessable) | Notified | 23/3/2023 | |
| 11/6/2009 | New Higher-risk Medicine Application | Abridged new higher-risk medicine not containing a new active substance | Granted 15/7/2010 | 11/6/2009 |
