Pilot T Support

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

Buy It Now

Active ingredient:
magnesium oxide,manganese sulfate monohydrate,pyridoxine hydrochloride,retinol acetate,zinc citrate trihydrate
Available from:
IVC Brunel Healthcare Pty Ltd
Authorization status:
Listed
Authorization number:
345955

Read the complete document

Public Summary

Summary for ARTG Entry:

345955

Pilot T Support

ARTG entry for

Medicine Listed

Sponsor

IVC Brunel Healthcare Pty Ltd

Postal Address

Po Box 7120 Riverside Centre, Brisbane, QLD, 4001

Australia

ARTG Start Date

15/10/2020

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 . Pilot T Support

Product Type

Single Medicine Product

Effective Date

26/11/2020

Permitted Indications

Maintain/support energy production

Maintain/support general health and wellbeing

Maintain/support immune system health

Helps maintain/support testosterone formation/synthesis

Maintain/support skin health

Indication Requirements

Product presentation must not imply or refer to serious immunological diseases.

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased

physical activity.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

WARNING - this medication may be dangerous when used in large amounts or for a long time; or WARNING - this product contains [insert pyridoxine

hydrochloride or pyridoxal 5-phosphate as applicable], which may be dangerous when used in large amounts or for a long time.

WARNING: May be dangerous if taken in large amounts or for a long period. OR WARNING: Contains zinc which may be dangerous if taken in large

amounts or for a long period (or words to that effect).

WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible.

[Contains vitamin B6].

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

Public Summary

Page 1 of

Produced at 12.01.2021 at 12:50:50 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

1 . Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

magnesium oxide

58 mg

Equivalent: magnesium

35 mg

manganese sulfate monohydrate

6.1 mg

Equivalent: manganese

2 mg

pyridoxine hydrochloride

36 mg

Equivalent: pyridoxine

30 mg

retinol acetate

.4427 mg

zinc citrate trihydrate

80 mg

Equivalent: zinc

25 mg

Other Ingredients (Excipients)

Acacia

calcium carbonate

croscarmellose sodium

dl-alpha-tocopherol

hypromellose

magnesium stearate

maize starch

maltodextrin

microcrystalline cellulose

purified talc

silicon dioxide

stearic acid

© 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 12.01.2021 at 12:50:50 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

Similar products

Search alerts related to this product

Share this information