PACLITAXEL

Main information

  • Trade name:
  • PACLITAXEL INTAS paclitaxel 100 mg/16.7 mL concentrated injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PACLITAXEL INTAS paclitaxel 100 mg/16.7 mL concentrated injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219552
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219552

PACLITAXEL INTAS paclitaxel 100 mg/16.7 mL concentrated injection vial

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

Level 24 570 Bourke Street,Melbourne, VIC, 3000

Australia

ARTG Start Date

2/02/2016

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 INTAS paclitaxel 100 mg/16.7 mL concentrated injection vial

Product Type

Single Medicine Product

Effective date

30/01/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

- Primary treatment of ovarian cancer in combination with a platinum agent. - Treatment of metastatic carcinoma of the ovary after failure of standard

therapy. - Treatment of metastatic carcinoma 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 metastatic disease. - 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. - for the treatment of non-small cell lung cancer (NSCLC).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. PACLITAXEL INTAS paclitaxel 100 mg/16.7 mL concentrated injection vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous Infusion

Visual Identification

A clear, colorless to slightly yellow solution in a clear glass vial with flip off

seal.

Active Ingredients

Paclitaxel

100 mg

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

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 03:37:27 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

21-9-2018

Pending EC decision:  Apealea, paclitaxel, Opinion date: 20-Sep-2018

Pending EC decision: Apealea, paclitaxel, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

1-8-2018

Abraxane (Celgene Europe B.V.)

Abraxane (Celgene Europe B.V.)

Abraxane (Active substance: paclitaxel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5212 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/778/T/91

Europe -DG Health and Food Safety