GETERO

Main information

  • Trade name:
  • GETERO gemcitabine (as hydrochloride) 1 g powder for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GETERO gemcitabine (as hydrochloride) 1 g powder for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 208003
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

208003

GETERO gemcitabine (as hydrochloride) 1 g powder for injection vial

ARTG entry for

Medicine Registered

Sponsor

Hetero Australia Pty Ltd

Postal Address

Level 5 Nexus Norwest 4 Columbia Court,BAULKHAM HILLS, NSW, 2153

Australia

ARTG Start Date

3/03/2015

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. GETERO gemcitabine (as hydrochloride) 1 g powder for injection vial

Product Type

Single Medicine Product

Effective date

3/03/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Gemcitabine is indicated for treatment of patients with locally advanced or metastatic non- small cell lung cancer.,Gemcitabine is indicated for treatment

of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine is also indicated for patients with 5-FU refractory

pancreatic cancer.,Gemcitabine, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer.,Gemcitabine, in

combination with paclitaxel, 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.,Gemcitabine,

in combination with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months

following platinum± based therapy

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

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial

(S4) Prescription Only Medicine

Components

1. GETERO gemcitabine (as hydrochloride) 1 g powder for injection vial

Dosage Form

Injection, powder for

Route of Administration

Intravenous Infusion

Visual Identification

White to off-white lyophilised powder to be reconstituted for intravenous

use.

Active Ingredients

Gemcitabine hydrochloride

1138 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 23.11.2017 at 08:40:47 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

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