Main information



  • Available in:
  • Swisse Men's Ultivite
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218375
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Swisse Men's Ultivite

ARTG entry for

Medicine Listed


Swisse Wellness Pty Ltd

Postal Address

111 Cambridge Street,Collingwood, VIC, 3066


ARTG Start Date


Product category




Approval area

Listed Medicines


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


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.

The Ginkgo biloba leaf extract used in the manufacture of this medicine must comply with the requirement of Identification Test B of the monograph

Powdered Ginkgo Extract in the United States Pharmacopeia 32 - National Formulary 27 (USP32-NF27) as in force or existing from time to time. This

condition does not apply to powdered or dried leaf.


1. Swisse Men's Ultivite

Product Type

Single Medicine Product

Effective date



The recommended dose of this medicine provides small amounts of caffeine

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.

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

Not for the treatment of iron deficiency conditions (or words to that effect).

'Contains gluten (or words to that effect)'

Do not take while on warfarin therapy without medical advice.

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

Standard Indications

May assist in the management of dietary iron deficiency.

Specific Indications

Folic acid, Iron, Vitamin B6 and Vitamin B12 support red blood cell formation. Iron

supports proper red blood cell function. A factor in the maintenance of good health/

Helps support general health and wellbeing. Swisse Men's Ultivite helps fill nutritional

gaps and maintain general well-being. Helps provide nutritional support during periods

of nervous tension and stress/ B vitamins help support/maintain a healthy nervous system. B

Vitamins help support energy production. Zinc helps maintain immune function/system. Zinc helps support connective tissue formation. Zinc helps to

maintain healthy skin. B complex vitamins are needed for the metabolism of food into energy, they assist with energy production, stamina, vitality.

Vitamin C, Grape Seed and Selenium act as antioxidants to help protect against

potential free radical damage/provide antioxidant support. Swisse Men's Ultivite has been shown in a clinical study to support/maintain healthy mood

balance. Swisse Men's Ultivite has been shown in a a clinical trial to help improve alertness.

Swisse Men's Ultivite has been shown in a clinical study to help support/maintain energy levels. Vitamin B2, Vitamin B3, Vitamin B5,Vitamin B6, Vitamin

B12, Vitamin C, folic acid, iron and magnesium contribute to a reduction in tiredness and fatigue/help relieve tiredness and fatigue. Pantothenic

Public Summary

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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.

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acid/Vitamin B5 contributes to/supports/assists normal/healthy mental performance. Zinc is essential for male reproductive health including healthy

sperm production. Zinc is required for the production of hormones such as testosterone. Vitamin C helps to support healthy immune

function/system/Vitamin C is

important for maintaining immune health. Vitamin C helps/is involved in the synthesis of

collagen which is important for skin health. B Vitamins in the body may be lower when

lifestyles include processed foods, alcohol, sugar, caffeine. Healthy adrenal gland

function plays an important role in individual's stress response. Vitamin B5 and vitamin

B6 are important for adrenal function, helping to support the adrenal glands during

periods of stress. During stress Vitamin B5 and B6 may be decreased/may be lower

during times of stress. Contains folic acid. Folic acid has a role in a number of reactions

in the body essential for normal brain function. Vitamin C is found in high concentrations in the adrenal glands. It is important for the synthesis of

hormones involved in the stress response/body's response to stress. Vitamin D helps to support bone health. Vitamin D helps in the absorption of


Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule


1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration


Visual Identification

Active Ingredients

Agathosma betulina

2.5 mg

Equivalent: Agathosma betulina (Dry)

10 mg

Apium graveolens

1.6 mg

Equivalent: Apium graveolens (Dry)

20 mg

Astragalus membranaceus

5 mg

Equivalent: Astragalus membranaceus (Dry)

50 mg

Avena sativa

50 mg

Equivalent: Avena sativa (Fresh)

500 mg

Berberis vulgaris

2.5 mg

Equivalent: Berberis vulgaris (Dry)

15 mg


5 mg


50 microgram

calcium ascorbate dihydrate

200 mg

Calcium citrate

100 mg

Calcium pantothenate

70 mg

Camellia sinensis

3.34 mg

Equivalent: Camellia sinensis (Dry)

20 mg

Carica papaya

10 mg

Equivalent: Carica papaya (Dry)

10 mg

Centella asiatica

12.5 mg

Equivalent: Centella asiatica (Dry)

50 mg

Choline bitartrate

25 mg

Chromium picolinate

50 microgram

Citrus bioflavonoids extract

40 mg


5 microgram

Copper gluconate

200 microgram

Crataegus monogyna

20 mg

Equivalent: Crataegus monogyna (Dry)

100 mg


30 microgram

Cynara scolymus

12.5 mg

Equivalent: Cynara scolymus (Fresh)

50 mg

d-alpha-Tocopheryl acid succinate

41.3 mg

Equisetum arvense

7.5 mg

Equivalent: Equisetum arvense (Dry)

30 mg

Ferrous fumarate

9.6 mg

Foeniculum vulgare

3 mg

Equivalent: Foeniculum vulgare (Dry)

15 mg

Public Summary

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Folic acid

500 microgram

Ginkgo biloba

2 mg

Equivalent: Ginkgo biloba (Dry)

100 mg

heavy magnesium oxide

100 mg


25 mg


200 microgram

Lycopersicon esculentum

2 mg

Equivalent: Lycopersicon esculentum (Fresh)

700 mg

Lysine hydrochloride

50 mg

Manganese amino acid chelate

12 mg


30 mg

Panax ginseng

16.67 mg

Equivalent: Panax ginseng (Dry)

50 mg

Petroselinum crispum

2.5 mg

Equivalent: Petroselinum crispum (Dry)

10 mg

potassium iodide

65 microgram

Potassium sulfate

8.9 mg

pyridoxine hydrochloride

30 mg


30 mg


65 microgram

Serenoa repens

20 mg

Equivalent: Serenoa repens (Dry)

200 mg

Silybum marianum

714.3 microgram

Equivalent: Silybum marianum (Dry)

50 mg

Smilax officinalis

12.5 mg

Equivalent: Smilax officinalis (Dry)

50 mg

Spearmint Oil

1.5 mg

Thiamine hydrochloride

30 mg

Turnera diffusa

24 mg

Equivalent: Turnera diffusa (Dry)

120 mg


1 mg


1 mg

Vaccinium myrtillus

250 microgram

Equivalent: Vaccinium myrtillus (Fresh)

25 mg

Vitis vinifera

9.9 mg

Equivalent: Vitis vinifera (Dry)

1.188 g

zinc amino acid chelate

30 mg

Zingiber officinale

1 mg

Equivalent: Zingiber officinale (Dry)

5 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

Public Summary

Page 3 of

Produced at 23.11.2017 at 12:52:05 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 for contact information