Biogency Piliant Tablets

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

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Active ingredient:
ascorbic acid,Biota orientalis,Biotin,colloidal anhydrous silica,cyanocobalamin,Centella asiatica,ferrous fumarate,folic acid,Ginkgo biloba,magnesium oxide,nicotinamide,nicotinic acid,pyridoxine hydrochloride,retinol acetate,riboflavin,thiamine hydrochloride,zinc gluconate
Available from:
Biogency Pty Ltd
Authorization status:
Listed
Authorization number:
352202

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Public Summary

Summary for ARTG Entry:

352202

Biogency Piliant Tablets

ARTG entry for

Medicine Listed

Sponsor

Biogency Pty Ltd

Postal Address

PO Box 649, Campsie, NSW, 2194

Australia

ARTG Start Date

23/12/2020

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.

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 . Biogency Piliant Tablets

Product Type

Single Medicine Product

Effective Date

23/12/2020

Permitted Indications

Enhance/improve/promote/increase hair growth

Maintain/support hair health

Maintain/support (state vitamin/mineral/nutrient) levels in the body

Indication Requirements

If product is indicated for supplementation, Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin

and/or mineral supplements should not replace a balanced diet.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Not recommended for use by pregnant and lactating women (or words to that effect).

Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not replace a balanced diet.

Keep out of reach of children (or words to that effect).

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Public Summary

Page 1 of

Produced at 11.01.2021 at 07:39:59 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

Active Ingredients

ascorbic acid

25 mg

Biota orientalis twig leafy Extract dry concentrate

300 mg

Equivalent: Biota orientalis (Dry)

Biotin

800 microgram

Centella asiatica leaf Extract dry concentrate

100 mg

Equivalent: Centella asiatica (Dry)

colloidal anhydrous silica

32.16 mg

Equivalent: silicon

15 mg

cyanocobalamin

1 microgram

ferrous fumarate

15.21 mg

Equivalent: iron

5 mg

folic acid

200 microgram

Ginkgo biloba leaf Extract dry concentrate

20 mg

Equivalent: Ginkgo biloba (Dry)

magnesium oxide

15 mg

nicotinamide

5 mg

nicotinic acid

100 mg

pyridoxine hydrochloride

61.7 microgram

Equivalent: pyridoxine

50 microgram

retinol acetate

52.9 microgram

Equivalent: vitamin A

44.85 microgram

riboflavin

500 microgram

thiamine hydrochloride

280 microgram

Equivalent: thiamine

250 microgram

zinc gluconate

34.84 mg

Equivalent: zinc

5 mg

Other Ingredients (Excipients)

Acacia

calcium hydrogen phosphate

Carnauba Wax

croscarmellose sodium

dl-alpha-tocopherol

hypromellose

iron oxide black

macrogol 3000

magnesium stearate

maize starch

maltodextrin

mannitol

microcrystalline cellulose

polyvinyl alcohol

purified talc

purified water

© 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 11.01.2021 at 07:39:59 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

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