Summary for ARTG Entry:
PACLITAXEL AN paclitaxel 100mg/16.7mL concentrated injection vial
ARTG entry for
Juno Pharmaceuticals Pty Ltd
Level 2 6 Bond Street,South Yarra, VIC, 3141
ARTG Start Date
Drug Safety Evaluation Branch
Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods
Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered
or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
1. PACLITAXEL AN paclitaxel 100mg/16.7mL concentrated injection vial
Single Medicine Product
See Product Information and Consumer Medicine Information for this product
PACLITAXEL AN is indicated for the treatment of : Primart treatment of ovarian cancer in combination with a platinum agent; Treatment of metastatic
carcinoma of the ovary and of the breast after failure of standard therapy; Adjuvant treatment of node positive breast cancer administered sequentially to
doxorubicin and cyclophosphamide; Treatment of metastatic cancer of the breast, in combination with trastuzumab (Herceptin), in patients who have
tumours that over-express HER-2 and who have not received previous chemotherapy for their metatastic disease; Treatment of non-small cell lung
cancer (NSCLC); In combination with gemcitabine (Gemzar), is indicated for the treatment of patients with unresectable, locally recurrent or metastatic
breast cancer who have relapsed following adjuvant/ neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless
Additional Product information
Glass Type I Clear
Store below 25
Protect from Light
Pack Size/Poison information
1 x 16.7mL vial
(S4) Prescription Only Medicine
1. Medicine Component
Route of Administration
Clear colourless to yellow viscous solution.
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