VINORELBINE AN vinorelbine (as tartrate) 10 mg/1 mL concentrated injection vial

Main information

  • Trade name:
  • VINORELBINE AN vinorelbine (as tartrate) 10 mg/1 mL concentrated injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VINORELBINE AN vinorelbine (as tartrate) 10 mg/1 mL concentrated injection vial
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 177539
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

177539

VINORELBINE AN vinorelbine (as tartrate) 10 mg/1 mL concentrated injection vial

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

18/01/2012

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. VINORELBINE AN vinorelbine (as tartrate) 10 mg/1 mL concentrated injection vial

Product Type

Single Medicine Product

Effective date

19/06/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of advanced breast cancer after failure of standard therapy, as a single agent or in combination; and as a first line treatment for advanced

non-small cell lung cancer, as a single agent or in combination.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

2 Years

Store at 2 to 8

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Refrigerate

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

Pack of 5 x 1 mL vials

(S4) Prescription Only Medicine

Pack of 1 x 1 mL vial

(S4) Prescription Only Medicine

Pack of 10 x 1 mL vials

(S4) Prescription Only Medicine

Components

1. VINORELBINE AN vinorelbine (as tartrate) 10 mg/1 mL concentrated injection vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous Infusion

Visual Identification

Clear solution

Active Ingredients

Vinorelbine tartrate

13.85 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 11:21:07 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