Swisse

Main information

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219664
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219664

Swisse Women's Ultivite

ARTG entry for

Medicine Listed

Sponsor

Swisse Wellness Pty Ltd

Postal Address

111 Cambridge Street,Collingwood, VIC, 3066

Australia

ARTG Start Date

28/01/2014

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.

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.

Products

1. Swisse Women's Ultivite

Product Type

Single Medicine Product

Effective date

28/01/2014

Warnings

'Contains gluten (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.

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

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

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

Do not exceed the stated dose except on medical advice. If you have had a baby with a neural tube defect/spina bifida, seek specific medical advice (or

words to that effect).

Contains lactose (or words to that effect).

Do not take while on warfarin therapy without medical advice.

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 Ultvite 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

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:42:29 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

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, they

assist with energy production, stamina and vitality. 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. 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. 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

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

Not recorded

Not recorded

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Apium graveolens

1 mg

Equivalent: Apium graveolens (Dry)

10 mg

Arctostaphylos uva-ursi

3.12 mg

Equivalent: Arctostaphylos uva-ursi (Dry)

12.5 mg

Astragalus membranaceus

2.5 mg

Equivalent: Astragalus membranaceus (Dry)

25 mg

Avena sativa

25 mg

Equivalent: Avena sativa (Fresh)

250 mg

Betacarotene

2.5 mg

Biotin

25 microgram

calcium ascorbate dihydrate

100 mg

Calcium citrate

50 mg

Calcium pantothenate

37.5 mg

Camellia sinensis

1.67 mg

Equivalent: Camellia sinensis (Dry)

10 mg

Carica papaya

5 mg

Centella asiatica

1.25 mg

Equivalent: Centella asiatica (Dry)

5 mg

Choline bitartrate

12.5 mg

Chromium picolinate

25 microgram

Citrus bioflavonoids extract

20 mg

colecalciferol

.0025 mg

Copper gluconate

208.5 microgram

Crataegus monogyna

3.75 mg

Equivalent: Crataegus monogyna (Dry)

15 mg

Cyanocobalamin

25 microgram

Cynara scolymus

6.25 mg

Equivalent: Cynara scolymus (Fresh)

25 mg

d-alpha-Tocopheryl acid succinate

20.66 mg

Eleutherococcus senticosus

1.25 mg

Equivalent: Eleutherococcus senticosus (Dry)

12.5 mg

Equisetum arvense

3.75 mg

Public Summary

Page 2 of

Produced at 23.11.2017 at 12:42:29 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

Equivalent: Equisetum arvense (Dry)

15 mg

Ferrous fumarate

7.94 mg

Foeniculum vulgare

1.7 mg

Equivalent: Foeniculum vulgare (Dry)

7.5 mg

Folic acid

250 microgram

Ginkgo biloba

50 microgram

Equivalent: Ginkgo biloba (Dry)

2.5 mg

Glycyrrhiza glabra

1.25 mg

Equivalent: Glycyrrhiza glabra (Dry)

5 mg

Inositol

12.5 mg

lutein

100 microgram

Lycopersicon esculentum

1 mg

Lysine hydrochloride

25 mg

Magnesium oxide

42.5 mg

Manganese amino acid chelate

8 mg

Matricaria chamomilla

1.88 mg

Equivalent: Matricaria chamomilla (Dry)

7.5 mg

Nicotinamide

25 mg

Petroselinum crispum

5 mg

potassium iodide

32.7 microgram

Potassium sulfate

2.23 mg

pyridoxine hydrochloride

25 mg

Riboflavin

25 mg

Selenomethionine

32.5 microgram

Silybum marianum

357 microgram

Spearmint Oil

750 microgram

Thiamine hydrochloride

25 mg

Ubidecarenone

500 microgram

Vaccinium myrtillus

125 microgram

Vitis vinifera

4.17 mg

zinc amino acid chelate

12.5 mg

Zingiber officinale

1.5 mg

Equivalent: Zingiber officinale (Dry)

7.5 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 http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 3 of

Produced at 23.11.2017 at 12:42:29 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