Main information



  • Available in:
  • MediHerb Vital Woman
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219928
  • Last update:
  • 09-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


MediHerb Vital Woman

ARTG entry for

Medicine Listed


Integria Healthcare Australia Pty Ltd

Postal Address



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.


1. MediHerb Vital Woman

Product Type

Single Medicine Product

Effective date



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

If you are pregnant, or considering becoming pregnant, do not take vitamin A supplements without consulting your doctor or pharmacist.

The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents

for men.

WARNING - When taken in excess of 3000 micrograms retinol equivalents, vitamin A can cause birth defects.

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.

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).

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

Standard Indications

Relief of pre-menstrual symptoms/syndrome. [Warning S required]

For mineral (may state the mineral) supplementation.

Source of iron. Iron is necessary for the formation of haemoglobin which transports oxygen to the tissues.

Source of iron. Can assist in maintaining normal blood. Blood tonic.

Source of iron. Can assist in maintaining normal blood.

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

May assist in the management of dietary vitamin B12 deficiency.

May assist in the management of dietary folate deficiency.

Prevention/treatment of vitamin [XX] and/or mineral [YY] and/or nutritional deficiencies (This indication is not be to used for the treatment of iron

deficiency conditions).

Source of vitamin B12. Can assist in maintaining normal blood. Blood tonic.

For vitamin (may state the vitamin) supplementation.

Provides a daily dose of 400-500mcg of folic acid or folate. Contains folic acid which, if taken daily for one month before conception and during

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:39:20 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

pregnancy, may reduce the risk of women having a child with birth defects of the brain and/or spinal chord such as the neural tube defects known as

spina bifida and anencephaly. [Warning NEUR required.]

Aids, assists or helps in the maintenance of general well-being

Specific Indications

Contains herbs that have been used in traditional herbal medicine as a tonic for women/female tonic.

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

Ascorbic acid

100 mg

Asparagus racemosus

200 mg

Equivalent: Asparagus racemosus (Dry)

1.2 g


150 microgram


26.46 mg

calcium hydrogen phosphate dihydrate

258.18 mg

Calcium pantothenate

50 mg

Choline bitartrate

25 mg

chromic chloride hexahydrate

1.28 mg


.025 mg


150 microgram

d-alpha-Tocopheryl acid succinate

41.32 mg

Folic acid

500 microgram


25 mg

Iron amino acid chelate

50 mg

Magnesium amino acid chelate

150 mg

Manganese amino acid chelate

20 mg

mixed (low-alpha type) tocopherols concentrate

20.001 mg

molybdenum trioxide

150 microgram


50 mg


30 microgram

potassium iodide

391 microgram

pyridoxine hydrochloride

50 mg

retinol palmitate

.556 mg

Reynoutria japonica

20 mg

Equivalent: Reynoutria japonica (Dry)


30 mg


124.2 microgram

Thiamine hydrochloride

50 mg

Vitex agnus-castus

25 mg

Equivalent: Vitex agnus-castus (Dry)

250 mg

zinc amino acid chelate

25 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 2 of

Produced at 23.11.2017 at 12:39:20 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