METAGENICS FIBROPLEX PLUS ORANGE

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

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Active ingredient:
acetyl levocarnitine hydrochloride,ascorbic acid,calcium hydrogen phosphate dihydrate,chromium nicotinate,glutamine,magnesium amino acid chelate,mecobalamin (co-methylcobalamin),monobasic potassium phosphate,nicotinamide,pyridoxine hydrochloride,riboflavin,selenomethionine,taurine,thiamine hydrochloride
Available from:
Metagenics (Aust) Pty Ltd
Authorization status:
Listed
Authorization number:
350478

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Public Summary

Summary for ARTG Entry:

350478

METAGENICS FIBROPLEX PLUS ORANGE

ARTG entry for

Medicine Listed

Sponsor

Metagenics (Aust) Pty Ltd

Postal Address

PO Box 675, VIRGINIA BC, QLD, 4014

Australia

ARTG Start Date

2/12/2020

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 . METAGENICS FIBROPLEX PLUS ORANGE

Product Type

Single Medicine Product

Effective Date

2/12/2020

Permitted Indications

Maintain/support energy levels

Maintain/support general health and wellbeing

Helps maintain/support healthy blood sugar/glucose

Decrease/reduce/relieve muscle cramps when dietary intake is inadequate

Maintain/support muscle function

Maintain/support healthy neuromuscular system/function

Maintain/support muscle relaxation

Aid/assist/helps glucose/sugar/carbohydrate metabolism

Helps prevent dietary (state vitamin/mineral/nutrient) deficiency

Support healthy stress response in the body

Decrease/reduce/relieve symptoms of premenstrual tension

Indication Requirements

Product presentation must not imply or refer to serious musculoskeletal or neurological conditions.

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.

Product presentation must not imply or refer to lowering or raising blood sugar/glucose levels from outside of the normal healthy range.

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

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

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

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

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

Public Summary

Page 1 of

Produced at 11.01.2021 at 09:27:30 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

[Contains vitamin B6].

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.

If symptoms persist consult your healthcare practitioner (or words to that effect).

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

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Powder, oral

Route of Administration

Oral

Visual Identification

Active Ingredients

acetyl levocarnitine hydrochloride

16.79 mg/g

ascorbic acid

42.86 mg/g

calcium hydrogen phosphate dihydrate

38.43 mg/g

Equivalent: calcium

8.95 mg/g

chromium nicotinate

35.71 microgram/g

Equivalent: chromium

3.57 microgram/g

glutamine

71.43 mg/g

magnesium amino acid chelate

428.57 mg/g

Equivalent: magnesium

42.86 mg/g

mecobalamin (co-methylcobalamin)

21.47 microgram/g

monobasic potassium phosphate

26 mg/g

Equivalent: potassium

7.47 mg/g

nicotinamide

7.14 mg/g

pyridoxine hydrochloride

7.15 mg/g

Equivalent: pyridoxine

5.88 mg/g

riboflavin

271.43 microgram/g

selenomethionine

8.93 microgram/g

Equivalent: selenium

3.57 microgram/g

taurine

85.71 mg/g

thiamine hydrochloride

4.29 mg/g

Other Ingredients (Excipients)

calcium hydrogen phosphate

citric acid

colloidal anhydrous silica

Flavour

malic acid

Steviol glycosides

© 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 09:27:30 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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