DOCETAXEL

Main information

  • Trade name:
  • DOCETAXEL INTAS 80 mg/4 mL docetaxel concentrated injection 80 mg/4 mL glass vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOCETAXEL INTAS 80 mg/4 mL docetaxel concentrated injection 80 mg/4 mL glass vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209474
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209474

DOCETAXEL INTAS 80 mg/4 mL docetaxel concentrated injection 80 mg/4 mL glass 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

17/02/2015

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 INTAS 80 mg/4 mL docetaxel concentrated injection 80 mg/4 mL glass vial

Product Type

Single Medicine Product

Effective date

4/10/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Breast Cancer: Docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy

has failed. ,Adjuvant Treatment of Breast cancer: Docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable

breast cancer with a primary tumour of greater than or equal to 1cm and less than 7 cm.,Non Small Cell Lung Cancer: Docetaxel 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 is indicated for the treatment of metastatic carcinoma of the ovary after failure of first-line or subsequent

chemotherapy.,Prostate Cancer: Docetaxel is indicated for the treatment of patients with androgen independent (hormone refractory) prostate

cancer.,Head and Neck Cancer: Docetaxel, 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

24 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

Pack of 1 vial

(S4) Prescription Only Medicine

Components

1. DOCETAXEL INTAS 80 mg/4 mL docetaxel concentrated injection 80 mg/4 mL glass vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous

Visual Identification

Supplied in single-dose vials as a sterile, pyrogen-free, non-aqueous,pale

yellow to brownish-yellow solution.

Active Ingredients

Docetaxel

80 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 27.11.2017 at 10:17:28 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

1-11-2018

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Taxespira (Hospira UK Limited)

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Docetaxel Teva (Teva B.V.)

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Docetaxel Accord (Accord Healthcare Limited)

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Docetaxel Accord (Active substance: Docetaxel) - Centralised - Yearly update - Commission Decision (2018)4341 of Wed, 04 Jul 2018

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Docetaxel Kabi (Fresenius Kabi Deutschland GmbH)

Docetaxel Kabi (Active substance: Docetaxel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3053 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2325/T/19

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Docetaxel

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Docetaxel (Active substance: Docetaxel) - Centralised - Art 28 - (PSUR - Commission Decision (2017)7984 of Mon, 27 Nov 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/1152/201611

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