HERCLON trastuzumab (rch) 150 mg powder for injection vial

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
Trastuzumab
Available from:
Roche Products Pty Ltd
INN (International Name):
Trastuzumab
Authorization status:
Registered
Authorization number:
291750

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Public Summary

Summary for ARTG Entry:

291750

HERCLON trastuzumab (rch) 150 mg powder for injection vial

ARTG entry for

Medicine Registered

Sponsor

Roche Products Pty Ltd

Postal Address

PO Box 255,DEE WHY, NSW, 2099

Australia

ARTG Start Date

15/09/2017

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. HERCLON trastuzumab (rch) 150 mg powder for injection vial

Product Type

Single Medicine Product

Effective date

15/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Early Breast Cancer

HERCLON is indicated for the treatment of patients with HER2-positive localised breast cancer following surgery, and in assocoation with chemotherapy

and, if applicable, radiotherapy.

Locally Advanced Breast Cancer

HERCLON is indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by

adjuvant HERCLON.

Metastatic Breast Cancer

HERCLON is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2: a) as monotherapy for the

treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease, b) in combination with taxanes for the

treatment of those patients who have not received chemotherapy for their metastatic disease; or c) in combination with an aromatase inhibitor for the

treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.

Advanced Gastric Cancer

HERCLON is indicated in combination with cisplatin and either capecitabine or 5-FU for the treatment of patients with HER2 positive advanced

adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

4 Years

Store at 2 to 8

degrees Celsius

Not recorded

Do not Freeze

Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial

(S4) Prescription Only Medicine

Components

1. HERCLON trastuzumab (rch) 150 mg powder for injection vial

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Visual Identification

Lyophilised powder: white to pale yellow in colour. Reconstituted solution:

colourless to pale yellow, clear to slightly opalescent liquid.

Active Ingredients

Trastuzumab

150 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 24.11.2017 at 07:47:23 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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