Hair Skin & Nails

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

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Active ingredient:
ascorbic acid,betacarotene,Biotin,Equisetum arvense,ferrous fumarate,selenomethionine,silicon dioxide,Vitis vinifera,zinc citrate dihydrate
Available from:
Evergreen Healthcare Pty Ltd
Authorization status:
Listed
Authorization number:
321473

Public Summary

Summary for ARTG Entry:

321473

Hair Skin & Nails

ARTG entry for

Medicine Listed

Sponsor

Evergreen Healthcare Pty Ltd

Postal Address

5 Conferta Close,Hillside, VIC, 3037

Australia

ARTG Start Date

8/08/2019

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.

Products

1. Hair Skin & Nails

Product Type

Single Medicine Product

Effective date

8/08/2019

Permitted Indications

Maintain/support collagen formation

Maintain/support collagen health

Maintain/support hair health

Maintain/support nail health/strength/thickness

Maintain/support connective tissue health

Aid/assist/helps connective tissue production/formation

Maintain/support skin health

Maintain/support skin integrity/structure

Maintain/support skin regeneration

Maintain/support wound healing

Indication Requirements

Label statement: If symptoms persist, talk to your health professional.

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

This product contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not

be exceeded.

Additional Product information

Public Summary

Page 1 of

Produced at 29.08.2019 at 05:17:11 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

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

ascorbic acid

90 mg

betacarotene

2 mg

Biotin

1 mg

Equisetum arvense

375 mg

Equivalent: Equisetum arvense (Dry)

1.5 g

ferrous fumarate

18.9 mg

selenomethionine

238.5 microgram

silicon dioxide

65 mg

Vitis vinifera

83.33 mg

zinc citrate dihydrate

43.8 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 29.08.2019 at 05:17:11 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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