Main information



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

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219648
  • 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



'Contains gluten (or words to that effect)'

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

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

Do not take while on warfarin therapy without medical advice.

Contains lactose (or words to that effect).

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

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.

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. 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. 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

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:43:45 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.

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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

Capsule, hard

Route of Administration


Visual Identification

Active Ingredients

Agathosma betulina

1.25 mg

Equivalent: Agathosma betulina (Dry)

5 mg

Apium graveolens

1 mg

Equivalent: Apium graveolens (Dry)

10 mg

Astragalus membranaceus

2.5 mg

Equivalent: Astragalus membranaceus (Dry)

25 mg

Avena sativa

25 mg

Equivalent: Avena sativa (Fresh)

250 mg

Berberis vulgaris

1.25 mg

Equivalent: Berberis vulgaris (Dry)

7.5 mg


2.5 mg


25 microgram

calcium ascorbate dihydrate

100 mg

Calcium citrate

50 mg

Calcium pantothenate

35 mg

Camellia sinensis

1.67 mg

Equivalent: Camellia sinensis (Dry)

10 mg

Carica papaya

5 mg

Centella asiatica

6.25 mg

Equivalent: Centella asiatica (Dry)

25 mg

Choline bitartrate

12.5 mg

Chromium picolinate

25 microgram

Citrus bioflavonoids extract

20 mg


.0025 mg

Copper gluconate

100 microgram

Crataegus monogyna

12.5 mg

Equivalent: Crataegus monogyna (Dry)

50 mg


15 microgram

Cynara scolymus

6.25 mg

Equivalent: Cynara scolymus (Fresh)

25 mg

d-alpha-Tocopheryl acid succinate

20.66 mg

Equisetum arvense

3.75 mg

Equivalent: Equisetum arvense (Dry)

15 mg

Ferrous fumarate

4.8 mg

Foeniculum vulgare

1.7 mg

Equivalent: Foeniculum vulgare (Dry)

7.5 mg

Folic acid

250 microgram

Ginkgo biloba

1 mg

Public Summary

Page 2 of

Produced at 23.11.2017 at 12:43:46 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

Equivalent: Ginkgo biloba (Dry)

50 mg

heavy magnesium oxide

50 mg


12.5 mg


100 microgram

Lycopersicon esculentum

1 mg

Lysine hydrochloride

25 mg

Manganese amino acid chelate

6 mg


15 mg

Panax ginseng

8.33 mg

Equivalent: Panax ginseng (Dry)

25 mg

Petroselinum crispum

5 mg

potassium iodide

33 microgram

Potassium sulfate

4.46 mg

pyridoxine hydrochloride

15 mg


15 mg


32.5 microgram

Serenoa repens

10 mg

Equivalent: Serenoa repens (Dry)

100 mg

Silybum marianum

357 microgram

Smilax officinalis

6.25 mg

Equivalent: Smilax officinalis (Dry)

25 mg

Spearmint Oil

750 microgram

Thiamine hydrochloride

15 mg

Turnera diffusa

12 mg

Equivalent: Turnera diffusa (Dry)

60 mg


500 microgram


500 microgram

Vaccinium myrtillus

125 microgram

Vitis vinifera

4.17 mg

zinc amino acid chelate

15 mg

Zingiber officinale

500 microgram

Equivalent: Zingiber officinale (Dry)

2.5 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 12:43:46 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