MediFem

Main information

Documents

Localization

  • Available in:
  • MediFem B
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220240
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220240

MediFem B

ARTG entry for

Medicine Listed

Sponsor

Nature's Bio Technology Pty Ltd

Postal Address

12/12-18 Victoria Street,LIDCOMBE, NSW, 2141

Australia

ARTG Start Date

18/02/2014

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.

Products

1. MediFem B

Product Type

Single Medicine Product

Effective date

18/02/2014

Warnings

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).

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).

Standard Indications

Source of folic acid. Can assist in maintaining normal blood. Blood tonic.

Source of iron. Can assist in maintaining normal blood.

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

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

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

Beneficial during times of stress. [Warning S required]

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

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.]

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

pregnancy, may reduce the risk of having a child with spina bifida/neural tube defects. [Warning NEUR required].

For vitamin (may state the vitamin) supplementation.

Source of folic acid. Can assist in maintaining normal blood.

Helps maintain normal blood/blood tonic (Note: These claims are appropriate for folic acid, vitamin B12 and iron, but must not imply anaemic conditions)

Protects capillaries.

Maintain health of capillaries.

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

For mineral (may state the mineral) supplementation.

Public Summary

Page 1 of

Produced at 22.11.2017 at 11:30:56 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

Specific Indications

* Assists in the maintenance of a normal/healthy cardiovascular system.

* Supports the health of the cardiovascular system.

* Supports red blood cell health.

* Folic acid can assist in maintaining normal blood.

* Folic acid is one of the nutrients necessary for the production of normal red blood cells.

* Contains nutrients that can assist in maintaining normal blood. Blood tonic.

* Contains nutrients that can assist in maintaining normal blood. Blood tonic.

* Supports the health of the red blood cells.

* Iron and vitamin B6 are involved in the formation of haemoglobin and therefore the transport and storage of oxygen in the body.

* Contains nutrients that are essential for the proper function of the immune system.

* Maintains a normal/healthy immune system.

* Supports the immune system by aiding the activity of the white blood cells and antibody response.

* Contains nutrients that play a vital role in many immune mechanisms.

* Contains nutrients that are involved in many immune mechanisms in the body and that support healthy immune function.

* Supports healthy functioning of the immune system.

* Contains important nutritional antioxidants / free radical scavengers.

* Contains antioxidant nutrients, which assist in protecting the body from the damaging effects of free radicals.

* Contains antioxidant nutrients, which assist in reducing the risk of cellular damage from free radicals.

* Contains important nutritional antioxidants and can therefore assist in protecting against potential free radical/oxidative damage.

* Protects the cells from free radical damage.

* Contains nutrients that are necessary for wound healing.

* Contains nutrients that are necessary for the maintenance of healthy skin.

* Supports skin repair and wound healing.

* Supports healthy skin.

* Supports healthy vision.

* Contains pantothenic acid, which is required for proper function of the adrenal gland.

* Pantothenic acid supports the adrenal glands in the making of cortisone and other adrenal hormones that counteract the stress response.

* The human body has increased requirements for the vitamins (especially the B group) and minerals during periods of stress.

* Vitamin B5 has long been considered the "anti-stress" vitamin because of its central role in adrenal function and cellular metabolism.

* Some of the B group vitamins, such as folic acid and vitamin B6 are involved in the manufacture and action of mood enhancing hormones such as

serotonin.

* Provides support to the nervous system.

* Supports healthy nervous system function.

* Supports the health and function of the nervous system.

* Contains nutrients essential for healthy nervous system function.

* Supports the health and function of the nervous system.

* Contains nutrients required in the body for nerve cell function and muscle action.

* Supports neuromuscular function.

* Vitamin B6 is involved in the synthesis of neurotransmitters such as dopamine, norepinephrine, and serotonin.

* Contains nutrients that are involved in the production of energy in the body.

* Contains nutrients that play a vital role in the production of ATP, or cellular energy.

* Supports daily energy levels.

* Supports an active lifestyle.

* Supports/maintains healthy brain function.

* Dunaliella salina is a rich source of beta-carotene.

* Supports healthy pregnancy.

* Supports the health of the growing baby during pregnancy.

* Assists in maintaining health of the mother and the baby during pregnancy and lactation.

* Contains essential nutrients for mother and baby.

* Supports the health of the mother and baby.

* Provides nutritional support before and during pregnancy, when nutritional requirements are increased.

* The B vitamins, Vitamin C, iron and iodine are required in higher amounts during pregnancy.

* Contains essential vitamins and minerals that are required during pregnancy and whilst breastfeeding.

* Contains nutrients that support a healthy pregnancy.

* Contains nutrients essential for carbohydrate, protein and fat metabolism.

* Supports healthy metabolism of proteins, carbohydrates and fats in the body.

* Vitamin B6 assists in the metabolism protein/amino acids and fats.

* Thiamine, pantothenic acid, riboflavin, biotin and cyanocobalamin are involved in the metabolism of carbohydrates in the body.

* Biotin functions in the human body as an essential co-factor for enzyme that are involved in the metabolism of carbohydrates, fats and proteins.

* Pantothenic acid, riboflavin and cyanocobalamin are involved in the metabolism of protein, or amino acids in the body.

* Thiamine, pantothenic acid, riboflavin and cyanocobalamin are involved in the metabolism of carbohydrates in the body.

* Contains nutrients that are involved in hormone synthesis and modulation.

* Vitamin C supports iron absorption.

* Vitamin C is necessary for the manufacture of collagen in the body.

* Vitamin C plays a role in collagen formation.

* Vitamin C supports the development and maintenance of bones.

* Vitamin C supports the development and maintenance of teeth.

* Vitamin C supports the development and maintenance of cartilage.

* Vitamin C supports connective tissue formation.

* Folic acid plays a role in DNA synthesis. Folic acid is therefore essential for healthy cellular division and healthy foetal development.

* Vitamin B12 is required for cell replication and nucleotide (DNA) synthesis.

* Contains Iodine. Iodine is necessary for the healthy brain development of the baby.

* Iodine is an essential nutrient required for normal thyroid function, and is important for a baby's brain, growth and development.

* Iodine plays an important role in foetal brain development.

* Iodine is important for the normal functioning of the thyroid gland as it is an essential nutrient required for the synthesis of thyroid hormones.

* Iodine is essential for healthy growth and development of the baby.

* Supports baby's brain development.

* Iodine plays an important role in normal/healthy growth and development.

* Iodine sufficiency is important for brain and intellectual development.

Additional Product information

Container information

Public Summary

Page 2 of

Produced at 22.11.2017 at 11:30:56 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

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

Not recorded

Not recorded

Child resistant closure

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

Ascorbic acid

55 mg

Biotin

30 microgram

Calcium pantothenate

4.917 mg

Cyanocobalamin

20 microgram

d-alpha-Tocopheryl acid succinate

7 mg

Dunaliella salina

60.05 mg

Ferrous fumarate

21.28 mg

Folic acid

500 microgram

heavy magnesium oxide

248.76 mg

Manganese gluconate

8.4 mg

Nicotinamide

4 mg

potassium iodide

200 microgram

pyridoxine hydrochloride

24.308 mg

Riboflavin

1.5 mg

Thiamine nitrate

2.467 mg

zinc oxide

4.61 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 22.11.2017 at 11:30:56 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