PACLITAXEL AGILA paclitaxel 100mg/16.7mL solution for injection vial

Main information

  • Trade name:
  • PACLITAXEL AGILA paclitaxel 100mg/16.7mL solution for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PACLITAXEL AGILA paclitaxel 100mg/16.7mL solution for injection vial
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 176336
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

176336

PACLITAXEL AGILA paclitaxel 100mg/16.7mL solution for injection vial

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

20/01/2011

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

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.

Products

1. PACLITAXEL AGILA paclitaxel 100mg/16.7mL solution for injection vial

Product Type

Single Medicine Product

Effective date

24/04/2013

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

PACLITAXEL AGILA is indicated for: Primary 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 clinically

contraindicated.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

2 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 x 16.7mL vial

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Injection, solution

Route of Administration

Intravenous

Visual Identification

Clear colourless to yellow viscous solution.

Active Ingredients

Paclitaxel

6 mg/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

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Public Summary

Page 1 of

Produced at 29.11.2017 at 01:05:34 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information