DOCETAXEL TEVA docetaxel 20 mg/0.72 mL concentrated injection vial with diluent vial

Main information

  • Trade name:
  • DOCETAXEL TEVA docetaxel 20 mg/0.72 mL concentrated injection vial with diluent vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOCETAXEL TEVA docetaxel 20 mg/0.72 mL concentrated injection vial with diluent vial
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 176657
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

176657

DOCETAXEL TEVA docetaxel 20 mg/0.72 mL concentrated injection vial with diluent vial

ARTG entry for

Medicine Registered

Sponsor

Teva Pharma Australia Pty Ltd

Postal Address

Locked Bag 2053,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

13/12/2012

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. DOCETAXEL TEVA docetaxel 20 mg/0.72 mL concentrated injection vial with diluent vial

Product Type

Composite Pack

Effective date

3/05/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Breast Cancer,Metastatic Breast Cancer,DOCETAXEL TEVA is indicated for the treatment of patients with locally advanced or metastatic breast cancer

in whom previous chemotherapy has failed.,DOCETAXEL TEVA in combination with capecitabine is indicated for the treatment of patients with locally

advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.,DOCETAXEL TEVA in combination with trastuzumab

is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received

chemotherapy for metastatic disease.,Adjuvant Treatment of Breast Cancer,DOCETAXEL TEVA in combination with doxorubicin and cyclophosphamide

is indicated for the adjuvant treatment of patients with node-positive breast cancer.,Doxorubicin and cyclophosphamide followed by DOCETAXEL TEVA

in combination with trastuzumab (AC-TH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress

HER2.,DOCETAXEL TEVA in combination with carboplatin and trastuzumab (TCH) is indicated for the adjuvant treatment of patients with operable

breast cancer whose tumours overexpress HER2.,DOCETAXEL TEVA in combination with cyclophosphamide is indicated for the adjuvant treatment of

operable breast cancer with a primary tumour of greater than or equal to 1 cm and less than 7 cm.,Non Small Cell Lung Cancer,DOCETAXEL TEVA is

indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer, including those who have failed platinum-based

chemotherapy.,Ovarian Cancer,DOCETAXEL TEVA is indicated for the treatment of metastatic carcinoma of the ovary after failure of first- line or

subsequent chemotherapy.,Prostate Cancer,DOCETAXEL TEVA is indicated for the treatment of patients with androgen independent (hormone

refractory) prostate cancer.,Head and Neck Cancer,DOCETAXEL TEVA, in combination with cisplatin and fluorouracil is indicated as induction treatment

prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability

of surgical cure, require organ preservation or where the tumour is technically unresectable.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

12 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. Solvent vial

Dosage Form

Injection, diluent for

Route of Administration

Intravenous

Visual Identification

Clear colourless solution

2. DOCETAXEL TEVA docetaxel 20 mg/0.72 mL concentrated injection vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous

Visual Identification

Clear yellow to brown yellow viscous solution

Active Ingredients

Public Summary

Page 1 of

Produced at 29.11.2017 at 12:40:48 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

Docetaxel

20 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 2 of

Produced at 29.11.2017 at 12:40:48 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