Men's Multivitamin with Probiotics

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

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Active ingredient:
betacarotene,Bifidobacterium animalis ssp lactis,Biotin,calcium ascorbate dihydrate,calcium carbonate,calcium pantothenate,chromium picolinate,colecalciferol,cyanocobalamin,d-alpha-tocopheryl acetate,ferrous fumarate,folic acid,heavy magnesium oxide,Lactobacillus acidophilus,Lactobacillus rhamnosus,menaquinone 7,nicotinamide,potassium iodide,pyridoxine hydrochloride,Panax ginseng,riboflavin,selenomethionine,Serenoa repens,thiamine nitrate,Tribulus terrestris,zinc citrate dihydrate
Available from:
Phytologic Holdings Pty Ltd
Authorization status:
Listed
Authorization number:
321554

Public Summary

Summary for ARTG Entry:

321554

Men's Multivitamin with Probiotics

ARTG entry for

Medicine Listed

Sponsor

Phytologic Holdings Pty Ltd

Postal Address

PO Box 6193,Alexandria, NSW, 2015

Australia

ARTG Start Date

9/08/2019

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.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted

in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office

of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors

of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified

of the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

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. Men's Multivitamin with Probiotics

Product Type

Single Medicine Product

Effective date

9/08/2019

Permitted Indications

Antioxidant/Reduce free radicals formed in the body

Helps reduce/decrease free radical damage to body cells

Maintain/support collagen formation

Maintain/support collagen health

Enhance/promote energy levels

Maintain/support energy levels

Helps convert (state food) into energy

Maintain/support body metabolism/metabolic rate

Helps enhance/promote/increase vitality

Maintain/support vitality

Maintain/support healthy eye function

Maintain/support eye health

Maintain/support healthy eyesight/vision

Helps enhance/promote general health and wellbeing

Maintain/support general health and wellbeing

Maintain/support hair health

Maintain/support teeth mineralisation

Traditionally used in Western herbal medicine to anti-inflammatory/relieve inflammation

Aid/assist/helps connective tissue production/formation

Maintain/support healthy body tissues

Public Summary

Page 1 of

Produced at 29.08.2019 at 05:10:07 AEST

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

Maintain/support body tissue repair/regeneration

Aids/assists healthy bone development/growth/building

Maintain/support bone mass/density/integrity

Maintain/support (state mineral) absorption in bones

Help maintain/support bone mineralisation

Vitamin D helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life

Helps maintain/supports health joint cartilage growth/development/production

Aid/assist healthy red blood cell production

Helps enhance/promote red blood cell health

Maintain/support red blood cell health

Helps maintain/support healthy blood sugar/glucose

Aid/assist/helps in the maintenance of blood levels of oxygen

Helps maintain/support transport of oxygen in the body

Aid/assist/helps oxygen transport to body tissues

Maintain/support cardiovascular system health

Maintain/support healthy cardiovascular system function

Maintain/support heart health

Maintain/support blood capillary health

Maintain/support healthy blood capillary health

Maintain/support healthy thyroid gland function

Maintain/support healthy thyroid hormones

Maintain/support thyroid gland health

Aid/assist thyroid hormone production

Maintain/support healthy digestive system function

Maintain/support intestinal good/beneficial/friendly flora

Helps enhance/improve/promote/increase healthy digestive system flora/good bacteria growth

Helps enhance/improve/promote/increase intestinal good/beneficial/friendly bacteria growth

Traditionally used in Western herbal medicine to hepatoprotectant/protect the liver

Maintain/support immune system health

Maintain/support healthy immune system function

Maintain/support healthy muscle contraction function

Maintain/support muscle health

Maintain/support muscle function

Maintain/support healthy neuromuscular system/function

Maintain/support muscle relaxation

Helps enhance/promote/increase absorption of dietary (state vitamin/mineral/nutrient)

Maintain/support absorption of dietary (state vitamin/mineral/nutrient)

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

Aid/assist/helps metabolism of (state vitamin/mineral/nutrient)

Traditionally used in Western herbal medicine to adaptogen/Help body adapt to stress

Support healthy stress response in the body

Maintain/support nerve conduction

Maintain/support neuromuscular function

Maintain/support nervous system health

Maintain/support nervous system function

Maintain/support reproductive system health

Maintain/support healthy sexual function

Traditionally used in Western herbal medicine to male tonic

Maintain/support sperm health

Maintain/support sperm motility

Maintain/support sperm production

Maintain/support healthy mucous membranes/mucous tissue of the respiratory tract

Maintain/support skin health

Maintain/support wound healing

Maintain/support skin repair/healing/regeneration

Public Summary

Page 2 of

Produced at 29.08.2019 at 05:10:07 AEST

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

Indication Requirements

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

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

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

Product presentation must not imply or refer to any thyroid related diseases.

Product presentation must not imply or refer to serious cardiovascular conditions.

Product presentation must not imply or refer to circulatory disorders/diseases/conditions e.g. thrombosis.

Indication only for use for medicines that contain vitamin D as an active ingredient. The medicines may only contain a maximum recommended daily dose

of 25 micrograms or less of vitamin D and as a min

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 bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis,

osteoporosis.

Product presentation must not imply or refer to vision correction, faults or serious eye disease e.g. macular degeneration.

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

Product presentation must not imply or refer to serious forms of respiratory disorders/diseases, such as: asthma, pneumonia, COAD, COPD, influenza.

Product presentation must not imply or refer to infertility.

Product presentation must not imply or refer to liver disease, such as cirrhosis, hepatitis.

Product presentation must not imply or refer to heart disease.

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 imply chronic fatigue syndrome.

Product presentation must not imply or refer to any form of arthritis or osteoarthritis unless qualified as mild.

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

Product presentation must not encourage excessive or harmful consumption of alcohol or other toxic substances.

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

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

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

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

betacarotene

.54 mg

Bifidobacterium animalis ssp lactis

3 billion CFU

Biotin

50 microgram

calcium ascorbate dihydrate

54.78 mg

calcium carbonate

249.75 mg

calcium pantothenate

1.64 mg

chromium picolinate

.4 mg

colecalciferol

.025 mg

cyanocobalamin

25 microgram

d-alpha-tocopheryl acetate

6.85 mg

ferrous fumarate

15.21 mg

Public Summary

Page 3 of

Produced at 29.08.2019 at 05:10:07 AEST

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

folic acid

300 microgram

heavy magnesium oxide

69.64 mg

Lactobacillus acidophilus

1 billion CFU

Lactobacillus rhamnosus

1 billion CFU

menaquinone 7

17.5 microgram

nicotinamide

25 mg

Panax ginseng

33.33 mg

Equivalent: Panax ginseng (Dry)

100 mg

potassium iodide

.2 mg

pyridoxine hydrochloride

30.39 mg

riboflavin

15 mg

selenomethionine

.062 mg

Serenoa repens

25 mg

Equivalent: Serenoa repens (Dry)

100 mg

thiamine nitrate

18.5 mg

Tribulus terrestris

10 mg

Equivalent: Tribulus terrestris (Dry)

500 mg

zinc citrate dihydrate

43.61 mg

© 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 4 of

Produced at 29.08.2019 at 05:10:07 AEST

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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