GEMCITABINE-GA gemcitabine (as hydrochloride) 200 mg/20 mL concentrated injection vial

Main information

  • Trade name:
  • GEMCITABINE-GA gemcitabine (as hydrochloride) 200 mg/20 mL concentrated injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GEMCITABINE-GA gemcitabine (as hydrochloride) 200 mg/20 mL concentrated injection vial
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 193200
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

193200

GEMCITABINE-GA gemcitabine (as hydrochloride) 200 mg/20 mL concentrated injection vial

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

4/02/2013

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. GEMCITABINE-GA gemcitabine (as hydrochloride) 200 mg/20 mL concentrated injection vial

Product Type

Single Medicine Product

Effective date

4/02/2013

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of patients with locally advanced or metastatic non-small celll lung cancer. Treatment of patients with locally advanced or metastatic

adenocarcinoma of the pancreas. Treatment of patients with 5-FU refractory pancreatic cancer. Treatment of patients with bladder cancer, alone or in

combination with cisplatin. Treatment, in combinatin with paclitaxel, 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.

Treatment, in combinatin with carboplatin, of patients with recurrent epithelial ovarian carcinoma, who have relapsed > six months following platinum

based therapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

6 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Do not Freeze

Do not Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. GEMCITABINE-GA gemcitabine (as hydrochloride) 200 mg/20 mL concentrated injection vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous Infusion

Visual Identification

Clear colourless solutin in a flint vial with a rubber stopper and aluminium

seal

Active Ingredients

Gemcitabine hydrochloride

227.705 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 28.11.2017 at 07:32:54 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