Hivita Luminous White Capsule

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

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Active ingredient:
ascorbic acid,d-alpha-tocopherol,Lycopersicon esculentum
Available from:
Hivita Pty Ltd
Authorization status:
Listed (Export Only)
Authorization number:
321303

Public Summary

Summary for ARTG Entry:

321303

Hivita Luminous White Capsule

ARTG entry for

Medicine Listed (Export Only)

Sponsor

Hivita Pty Ltd

Postal Address

PO Box 698,HURSTVILLE BC, NSW, 1481

Australia

ARTG Start Date

5/08/2019

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. Hivita Luminous White Capsule

Product Type

Single Medicine Product

Effective date

7/08/2019 3:46:48 PM

Permitted Indications

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

No Warnings included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Not recorded

Not recorded

Not recorded

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1.

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Brown orange paste filled in a pink coloured oblong shaped soft gelatin

capsule size 22 minim oblong.

Active Ingredients

ascorbic acid

50 mg

d-alpha-tocopherol

10.07 mg

Lycopersicon esculentum

500 mg

Equivalent: Lycopersicon esculentum (Fresh)

30 g

Public Summary

Page 1 of

Produced at 29.08.2019 at 05:32:18 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

© 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 2 of

Produced at 29.08.2019 at 05:32:18 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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