APO-Bortezomib

Main information

  • Trade name:
  • APO-Bortezomib bortezomib 3.5mg powder for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-Bortezomib bortezomib 3.5mg powder for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215827
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215827

APO-Bortezomib bortezomib 3.5mg powder for injection vial

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

22/07/2015

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. APO-Bortezomib bortezomib 3.5mg powder for injection vial

Product Type

Single Medicine Product

Effective date

9/09/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Bortezomib, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are

not candidates for high dose chemotherapy.,Bortezomib, as part of combination therapy, is indicated for induction therapy prior to high dose

chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,Bortezomib is also

indicated for the treatment of multiple myeloma patients who have received at least one prior therapy and who have progressive disease.

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

(S4) Prescription Only Medicine

Components

1. APO-Bortezomib bortezomib 3.5mg powder for injection vial

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Subcutaneous

Visual Identification

White to off-white powder

Active Ingredients

Bortezomib

3.5 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 26.11.2017 at 08:05:17 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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