METAGENICS FEMME ESSENTIALS MULTIVITAMIN and MINERAL

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

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Active ingredient:
ascorbic acid,betacarotene,borax,Biotin,Brassica oleracea var. italica,calcium amino acid chelate,calcium citrate tetrahydrate,calcium hydrogen phosphate dihydrate,calcium pantothenate,chromic chloride hexahydrate,colecalciferol,d-alpha-tocopheryl acid succinate,dibasic potassium phosphate,folic acid,iron amino acid chelate,magnesium amino acid chelate,manganese amino acid chelate,mecobalamin (co-methylcobalamin),mixed (low-alpha type) tocopherols concentrate,molybdenum
Available from:
Metagenics (Aust) Pty Ltd
Authorization status:
Listed
Authorization number:
347552

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Public Summary

Summary for ARTG Entry:

347552

METAGENICS FEMME ESSENTIALS MULTIVITAMIN and MINERAL

ARTG entry for

Medicine Listed

Sponsor

Metagenics (Aust) Pty Ltd

Postal Address

PO Box 675, VIRGINIA BC, QLD, 4014

Australia

ARTG Start Date

6/11/2020

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 FEMME ESSENTIALS MULTIVITAMIN and MINERAL

Product Type

Single Medicine Product

Effective Date

6/11/2020

Permitted Indications

Antioxidant/Reduce free radicals formed in the body in females

Maintain/support energy production in females

Maintain/support bone health in females

Maintain/support blood health in females

Maintain/support heart health in females

Maintain/support muscle function in females

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

Maintain/support cognitive function/mental function in females

Maintain/support brain function in females

Maintain/support nervous system function in females

Decrease/reduce/relieve symptoms of premenstrual tension

Maintain/support healthy reproductive hormones in females

Indication Requirements

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 serious cardiovascular conditions.

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

Note: this requirement is not intended to apply where the indications referring to osteoporosis specified in column 2 of Table 2 of this instrument are also

used.

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

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.

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

Product presentation must not imply or refer to hormone imbalances.

Standard Indications

No Standard Indications included on Record

Public Summary

Page 1 of

Produced at 11.01.2021 at 11:22:18 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

Specific Indications

No Specific Indications included on Record

Warnings

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 medicine 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.

Not to be taken by children under 2 years old (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

Active Ingredients

ascorbic acid

50 mg

betacarotene

4 mg

Biotin

50 microgram

borax

26.54 mg

Equivalent: boron

3.01 mg

Brassica oleracea var. italica sprout Powder

100 mg

calcium amino acid chelate

100 mg

Equivalent: calcium

20 mg

calcium citrate tetrahydrate

189.75 mg

Equivalent: calcium

40 mg

calcium hydrogen phosphate dihydrate

171.75 mg

Equivalent: calcium

40 mg

calcium pantothenate

50 mg

chromic chloride hexahydrate

768.84 microgram

Equivalent: chromium

150 microgram

colecalciferol

.0125 mg

d-alpha-tocopheryl acid succinate

25 mg

Equivalent: d-alpha-tocopherol

20.26 mg

dibasic potassium phosphate

77.95 mg

Equivalent: potassium

35 mg

folic acid

400.06 microgram

iron amino acid chelate

25 mg

Equivalent: iron

5 mg

magnesium amino acid chelate

100 mg

Equivalent: magnesium

10 mg

manganese amino acid chelate

15.63 mg

Equivalent: manganese

2.5 mg

mecobalamin (co-methylcobalamin)

400 microgram

mixed (low-alpha type) tocopherols concentrate

2.499 mg

molybdenum trioxide

150.04 microgram

Equivalent: molybdenum

100 microgram

nicotinamide

100 mg

Public Summary

Page 2 of

Produced at 11.01.2021 at 11:22:19 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

phytomenadione

.08 mg

potassium iodide

391.11 microgram

Equivalent: iodine

299 microgram

pyridoxal 5-phosphate

5 mg

Equivalent: pyridoxine

3.19 mg

pyridoxine hydrochloride

40 mg

Equivalent: pyridoxine

32.91 mg

riboflavin

20 mg

selenomethionine

65 microgram

Equivalent: selenium

26 microgram

thiamine hydrochloride

50 mg

zinc sulfate monohydrate

27.55 mg

Equivalent: zinc

10.04 mg

Other Ingredients (Excipients)

Acacia

calcium hydrogen phosphate dihydrate

calcium hydrogen phosphate

citric acid

croscarmellose sodium

dl-alpha-tocopherol

glycerol

hypromellose

liquid glucose

magnesium stearate

maize starch

maltodextrin

medium chain triglycerides

microcrystalline cellulose

potable water

silicon dioxide

sodium ascorbate

Soya Oil

starch sodium octenyl succinate

sucrose

© 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 3 of

Produced at 11.01.2021 at 11:22:19 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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