OptiSystems+

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

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Active ingredient:
creatine,cysteine,taurine
Available from:
Blue Lake Health
Authorization status:
Listed
Authorization number:
346491

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Public Summary

Summary for ARTG Entry:

346491

OptiSystems+

ARTG entry for

Medicine Listed

Sponsor

Blue Lake Health

Postal Address

5 Iredale Avenue, Cremorne, NSW, 2090

Australia

ARTG Start Date

23/10/2020

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 . OptiSystems+

Product Type

Single Medicine Product

Effective Date

23/10/2020

Permitted Indications

Maintain/support body waste elimination

Enhance/promote energy levels

Maintain/support energy levels

Helps improve/promote body metabolism/metabolic rate

Maintain/support body metabolism/metabolic rate

Maintain/support energy production

Helps enhance/promote body energy reserves

Enhance/improve/promote/increase memory/recall

Maintain/support memory/mental recall

Enhance/improve/promote/increase short term memory

Maintain/support brain function

Maintain/support brain health

Brain tonic/Enhance brain health

Helps enhance/promote healthy nerve conduction/transmission/neurotransmission

Maintain/support nerve conduction

Maintain/support brain/central nervous system development

Maintain/support nervous system function

Indication Requirements

Product presentation must only refer to detoxification in relation to natural body processes.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

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.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

Product presentation must not imply or refer to drugs/alcohol.

Product presentation must not imply or refer to neurological conditions or developmental delays.

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

Public Summary

Page 1 of

Produced at 12.01.2021 at 12:12:09 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

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

No Warnings included on Record

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

creatine

100 mg

cysteine

70 mg

taurine

205 mg

Other Ingredients (Excipients)

colloidal anhydrous silica

hypromellose

magnesium stearate

microcrystalline cellulose

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 12.01.2021 at 12:12:09 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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