TOPOTECAN CH topotecan (as hydrochloride) 4 mg powder for injection vial

Main information

  • Trade name:
  • TOPOTECAN CH topotecan (as hydrochloride) 4 mg powder for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TOPOTECAN CH topotecan (as hydrochloride) 4 mg powder for injection vial
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 178011
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

178011

TOPOTECAN CH topotecan (as hydrochloride) 4 mg powder for injection vial

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

30/03/2012

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. TOPOTECAN CH topotecan (as hydrochloride) 4 mg powder for injection vial

Product Type

Single Medicine Product

Effective date

22/04/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

TOPOTECAN CH for Injection is indicated as single agent therapy for the treatment of patients with:

- Small cell lung carcinoma after failure of first line chemotherapy;

- Metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.

TOPOTECAN CH for Injection is indicated in combination with cisplatin for the treatment of patients with:

- Histologically confirmed Stage IV-B, recurrent, or persistent carcinoma of the cervix, which is not amenable to curative treatment with surgery and/or

radiation 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

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

Pack of 1 vial

(S4) Prescription Only Medicine

Components

1. TOPOTECAN CH topotecan (as hydrochloride) 4 mg powder for injection vial

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Visual Identification

Light yellow to greenish powder

Active Ingredients

topotecan hydrochloride

4.346 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 29.11.2017 at 10:46:57 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