Bio Solution Vita King

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

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Active ingredient:
Angelica polymorpha,calcium hydrogen phosphate,d-alpha-tocopherol,Deer velvet antler powder,lecithin,Rehmannia glutinosa,squalene,Vitis vinifera,Zingiber officinale,Ziziphus jujuba
Available from:
Bio Solution Pty Ltd
Authorization status:
Listed
Authorization number:
323161

Public Summary

Summary for ARTG Entry:

323161

Bio Solution Vita King

ARTG entry for

Medicine Listed

Sponsor

Bio Solution Pty Ltd

Postal Address

Unit 45 29 Bennelong Rooad,Wentworth Point, NSW, 2127

Australia

ARTG Start Date

13/09/2019

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in

the list of 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine,

(b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is

sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be

kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records

to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted

in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office

of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors

of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified

of the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine

outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National

Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Preparations, for the purpose of Item 3, Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990 (the Regulations), that contain 'deer velvet

antler powder' as the therapeutically active ingredient aresubject to the following conditions: (i) the preparations are for oral use only (ii) the antlers

(including the velvet) are sourced only from red deer (Cervus elaphus), elk/wapiti (Cervus canadensis), or a crossbreed of these species (iii) the deer are

sourced only from farmed stock bred and raised in New Zealand (iv) the deer are sourced only from herds farmed for food in accordance with the Animal

Products Act 1999 (New Zealand) and the regulations made under that Act and (v) the antlers are removed from the deer only according to the Animal

Welfare Act 1999 (New Zealand) and the regulations made under that Act.

Products

1. Bio Solution Vita King

Product Type

Single Medicine Product

Effective date

13/09/2019

Permitted Indications

Antioxidant/Reduce free radicals formed in the body

Traditionally used in Chinese medicine to tonify/nourish/strengthen/replenish Qi

Traditionally used in Chinese medicine to enhance/promote energy levels

Traditionally used in Chinese medicine to helps enhance/promote general health and wellbeing

Traditionally used in Chinese medicine to helps enhance/promote healthy liver function

Traditionally used in Chinese medicine to enhance/improve/promote immune defence/immunity

Traditionally used in Chinese medicine to maintain/support healthy sexual function

Traditionally used in Chinese medicine to maintain/support kidney function

Indication Requirements

Product presentation must not imply or refer to liver disease, such as cirrhosis, hepatitis.

Product presentation must not imply or refer to kidney disease.

Product presentation must not imply or refer to imply chronic fatigue syndrome.

If TCM terminology is used on medicine label, label statement: Talk to a TCM practitioner/health professional if you are unsure if this medicine is right for

you.

Standard Indications

Public Summary

Page 1 of

Produced at 29.09.2019 at 04:47:53 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

No Standard Indications included on Record

Specific Indications

Warnings

No Warnings included on Record

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

Angelica polymorpha

28 mg

Equivalent: Angelica polymorpha (Dry)

140 mg

calcium hydrogen phosphate

20 mg

d-alpha-tocopherol

10 mg

Deer velvet antler powder

130 mg

lecithin

10 mg

Rehmannia glutinosa

10 mg

Equivalent: Rehmannia glutinosa (Dry)

20 mg

squalene

600 mg

Vitis vinifera

1 mg

Equivalent: Vitis vinifera (Dry)

120 mg

Zingiber officinale

2 mg

Equivalent: Zingiber officinale (Dry)

10 mg

Ziziphus jujuba

5 mg

Equivalent: Ziziphus jujuba (Dry)

10 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 2 of

Produced at 29.09.2019 at 04:47:53 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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