Biological Therapies Sodium Ascorbate Solution 30 g in 100 mL Injection Vial

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

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Active ingredient:
sodium ascorbate
Available from:
Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies
Authorization status:
Listed (Export Only)
Authorization number:
322560

Public Summary

Summary for ARTG Entry:

322560

Biological Therapies Sodium Ascorbate Solution 30 g in 100 mL Injection Vial

ARTG entry for

Medicine Listed (Export Only)

Sponsor

Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies

Postal Address

PO Box 702,BRAESIDE, VIC, 3195

Australia

ARTG Start Date

2/09/2019

Product category

Medicine

Status

Active

Approval area

Export only Medicines

Conditions

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods

on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to

substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription

Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

The sponsor shall hold stability data to support the claimed shelf life of the listed medicine according to the labelled storage conditions except where: (i)

each overseas importer accepts responsibility for holding stability data for this product; (ii) the sponsor has a written agreement to this effect from each

overseas importer; and (iii) the sponsor retains copies of all such agreements while the medicine remains listed on the ARTG.

This product must not be supplied for sale in Australia, including supply via duty free outlets.

Products

1. Biological Therapies Sodium Ascorbate Solution 30 g in 100 mL Injection Vial

Product Type

Single Medicine Product

Effective date

2/09/2019

Permitted Indications

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Sodium ascorbate solution injection for intravenous infusion is indicated for the treatment of vitamin C deficiency when oral treatment is not feasible.

Warnings

No Warnings included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

3 Years

Store at 2 to 8

degrees Celsius

Not recorded

Do not Freeze

Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1.

Dosage Form

Injection, intravenous infusion

Route of Administration

Intravenous

Visual Identification

Clear and colourless straw coloured solution

Active Ingredients

sodium ascorbate

300 mg/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

Public Summary

Page 1 of

Produced at 29.09.2019 at 05:49:01 AEST

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

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 29.09.2019 at 05:49:01 AEST

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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