Main information



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

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218377
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Swisse Women'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 Women's Ultivite

Product Type

Single Medicine Product

Effective date



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

'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.

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.

The recommended dose of this medicine provides small amounts of caffeine

Standard Indications

May assist in the management of dietary iron deficiency.

Specific Indications

Folate, 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 Women's Ultivite helps fill nutritional gaps and maintain general wellbeing. 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. Helps support Women's health and wellbeing/Helps support women's nutritional needs. For supplementation of Vitamin B1, B2, B3, B5, B6, Folate,

Biotin, Vitamin C, Vitamin D, Vitamin E, Chromium, Iodine, Manganese, Selenium, zinc. Vitamin C, Selenium and Grape seed extract act as antioxidants

to help protect against potential free radical Damage/provide antioxidant support. B complex vitamins are needed for the metabolism of food into energy,


assist with energy production, stamina and vitality. Swisse Women's Ultivite has been shown in a clinical trial to support/maintain healthy mood balance.

Swisse Women's Ultivite has been shown in a clinical trial to help support/maintain energy levels. Vitamin B2, Vitamin B3,

Vitamin B5, Vitamin B6, Vitamin B12, Vitamin C, Folic acid and Iron

contribute to a reduction in tiredness and fatigue/help relieve tiredness and fatigue. Vitamin C helps to support healthy immune function/system/Vitamin

Public Summary

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Produced at 23.11.2017 at 12:51:02 AEDT

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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. 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 calcium. Contains folic acid. Folic acid

has a role in a number of reactions in the body essential for normal brain function.

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

Apium graveolens

1.6 mg

Equivalent: Apium graveolens (Dry)

20 mg

Arctostaphylos uva-ursi

5 mg

Equivalent: Arctostaphylos uva-ursi (Dry)

25 mg

Astragalus membranaceus

5 mg

Equivalent: Astragalus membranaceus (Dry)

50 mg

Avena sativa

50 mg

Equivalent: Avena sativa (Fresh)

500 mg


5 mg


50 microgram

calcium ascorbate dihydrate

200 mg

Calcium citrate

200 mg

Calcium pantothenate

75 mg

Camellia sinensis

3.34 mg

Equivalent: Camellia sinensis (Dry)

20 mg

Carica papaya

10 mg

Equivalent: Carica papaya (Dry)

10 mg

Centella asiatica

2.5 mg

Equivalent: Centella asiatica (Dry)

10 mg

Choline bitartrate

25 mg

Chromium picolinate

50 microgram

Citrus bioflavonoids extract

40 mg


5 microgram

Copper gluconate

417 microgram

Crataegus monogyna

6 mg

Equivalent: Crataegus monogyna (Dry)

30 mg


50 microgram

Cynara scolymus

12.5 mg

Equivalent: Cynara scolymus (Fresh)

50 mg

d-alpha-Tocopheryl acid succinate

41.3 mg

Eleutherococcus senticosus

2.5 mg

Equivalent: Eleutherococcus senticosus (Dry)

25 mg

Equisetum arvense

7.5 mg

Equivalent: Equisetum arvense (Dry)

30 mg

Ferrous fumarate

16.01 mg

Foeniculum vulgare

3 mg

Equivalent: Foeniculum vulgare (Dry)

15 mg

Folic acid

500 microgram

Ginkgo biloba

100 microgram

Equivalent: Ginkgo biloba (Dry)

5 mg

Glycyrrhiza glabra

2.5 mg

Public Summary

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Produced at 23.11.2017 at 12:51:02 AEDT

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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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Equivalent: Glycyrrhiza glabra (Dry)

10 mg

heavy magnesium oxide

81.46 mg


25 mg


200 microgram

Lycopersicon esculentum

2 mg

Equivalent: Lycopersicon esculentum (Fresh)

700 mg

Lysine hydrochloride

50 mg

Manganese amino acid chelate

16 mg

Matricaria chamomilla

3.75 mg

Equivalent: Matricaria chamomilla (Dry)

15 mg


50 mg

Petroselinum crispum

2.5 mg

Equivalent: Petroselinum crispum (Dry)

10 mg

potassium iodide

65 microgram

Potassium sulfate

4.45 mg

pyridoxine hydrochloride

50 mg


50 mg


65 microgram

Silybum marianum

714.3 microgram

Equivalent: Silybum marianum (Dry)

50 mg

Spearmint Oil

1.5 mg

Thiamine hydrochloride

50 mg


1 mg

Vaccinium myrtillus

250 microgram

Equivalent: Vaccinium myrtillus (Fresh)

25 mg

Vitis vinifera

8.334 mg

Equivalent: Vitis vinifera (Dry)

zinc amino acid chelate

25 mg

Zingiber officinale

3 mg

Equivalent: Zingiber officinale (Dry)

15 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 12:51:02 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