Nourex Professional Pregnancy

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
Ascorbic acid,Biotin,colecalciferol,Calcium pantothenate,Copper gluconate,Cyanocobalamin,d-alpha-Tocopheryl acid succinate,Ferrous fumarate,Folic acid,Hydroxyapatite,Magnesium oxide,Manganese amino acid chelate,Nicotinamide,pyridoxine hydrochloride,Potassium iodide,Riboflavin,Selenomethionine,Thiamine nitrate,Zinc gluconate
Available from:
PBA Wholesale Pty Ltd
INN (International Name):
Ascorbic acid,Biotin,colecalciferol,Calcium pantothenate,Copper gluconate,Cyanocobalamin,d-alpha-Tocopheryl acid succinate,Ferro
Authorization number:
292239

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Public Summary

Summary for ARTG Entry:

292239

Nourex Professional Pregnancy

ARTG entry for

Medicine Listed

Sponsor

PBA Wholesale Pty Ltd

Postal Address

PO Box 1001,TOOWONG, QLD, 4066

Australia

ARTG Start Date

31/07/2017

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. Nourex Professional Pregnancy

Product Type

Single Medicine Product

Effective date

16/10/2017

Warnings

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).

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

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

Eyes formula. Support of healthy eye function.

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

Source of iron. Can assist in maintaining normal blood.

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

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.

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

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

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

May assist in the prevention of mineral [XX] deficiency when dietary intake is inadequate

May assist in the prevention of vitamin [XX] deficiency when dietary intake is inadequate

Maintenance of healthy eyes.

Maintain/support eye health

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

Public Summary

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Produced at 23.11.2017 at 07:43:28 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

pregnancy, may reduce the risk of having a child with spina bifida/neural tube defects. [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 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 minimum daily dose of 400-500micrograms of folic acid or folate. If taken daily when trying to conceive and during the first trimester of

pregnancy and/or for at least four weeks before conception and during the first trimester of pregnancy, folic acid may help to prevent neural tube defects

such as spina bifida and/or anencephaly. [Warning NEUR required]

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

Specific Indications

* Contains Folic acid, which supports a healthy pregnancy.

* Folic acid supports the health of the growing baby during pregnancy.

* Contains Iodine, which is essential for normal growth and development.

* Contains Iodine, which is required for normal brain development and cognition.

* Contains Iodine, which is an important nutrient for nervous system development.

* Maternal intake of Iodine is essential for normal growth and development during the foetal, neonatal and

infancy stages.

* Iodine is important for brain and intellectual development of baby/child.

* Contains Zinc, which is essential for proper growth and development.

* Iron is necessary for growth & development.

* Iron contributes to normal cognitive development in children.

* Contains Thiamine, which supports normal growth.

* Contains Vitamin B 12, which is an essential growth factor

* Contains Vitamin 812, which is involved in cell growth and replication.

* Contains Vitamin 812, which supports healthy cellular function.

* A marked increase in the maternal blood supply during pregnancy increases the demand for iron.

* Iron supplementation may help pregnant women meet the recommended intake for iron, when taken in

conjunction with a healthy diet.

* Contains Zinc, which is involved in DNA, RNA and protein synthesis.

* Contains Magnesium, which is involved in the synthesis of DNA and RNA.

* Contains Magnesium, which is required for the synthesis of DNA and RNA.

* Contains Vitamin D, which is involved in the regulation of cell growth, proliferation, differentiation and

apoptosis.

* Contains Folic acid, which is essential for proper cellular division.

* Contains Folic acid, which is involved in the formation of DNA and cellular division.

* Contains Folic acid, which plays a vital role in the synthesis of DNA.

* Contains Pyridoxine (Vitamin 86), which s nvolved in DNA synthesis.

* Contains Vitamin B12, which is involved in DNA synthesis.

* Contains Zinc, which plays an important role in reproduction.

* Zinc s necessary for ovulation and fertilisation.

* Zinc plays a necessary role in the metabolism of reproductive hormones.

* Zinc plays a necessary role in the metabolism of androgens, oestrogen and progesterone.

* Pantothenic acid is involved in normal/healthy hormone synthesis.

* Contains Pantothenic acid, which contributes to normal synthesis and metabolism of steroid hormones.

* Contains Pantothenic acid, which is required for the synthesis of cholesterol and steroid hormones.

* Pantothenic acid is involved in the production of energy in the body.

* Pantothenic acid plays a vital role in the production of ATP, or cellular energy.

* Pantothenic acid is essential for carbohydrate, protein and fat metabolism.

* Contains Manganese, which contributes to normal energy metabolism

* Contains Copper, which s involved in the production of cellular energy.

* Copper is involved in energy production within the body.

* Contains Magnesium, which is involved in energy production.

* Contains Magnesium, which is required for the production of energy in the body

* Iron plays a role in energy production in the body.

* Contains Riboflavin, which participates in essential reactions in the body, especially those that yield energy.

* Contains Riboflavin, which is involved in energy production n the body.

* Contains Riboflavin, which contributes to normal energy release from food.

* Contains Nicotinamide (Niacin), which is involved in the production of energy in the body.

* Contains Nicotinamide (Niacin), which is necessary for normal energy release from food.

* Contains pyridoxine (Vitamin 86), which is involved in energy production in the body.

* Contains Pyridoxine (Vitamin B6, which contributes to normal energy metabolism.

* Contains Zinc, which helps the body to metabolise proteins, carbohydrates and fats.

* Contains Magnesium, which is involved in carbohydrate and lipid metabolism.

* Contains Zinc, which plays an important role n the metabolism of proteins, carbohydrates and fats.

* Contains Biotin, which helps the body metabolise carbohydrates, fats and proteins.

* Contains Biotin, which is involved in the metabolism of carbohydrates, fats and proteins.

* Contains Biotin, which is involved in the production of energy in the body.

* Pantothenic acid supports healthy metabolism of proteins, carbohydrates and fats in the body.

* Contains Manganese, which is involved in carbohydrate and amino acid metabolism

* Contains Manganese, which is involved in the metabolism of carbohydrates and amino acids.

* Contains Magnesium, which is involved in protein synthesis.

* Contains Magnesium, which is involved in amino acid activation.

* Contains Vitamin C, which aids in the metabolism and synthesis of fats and proteins.

* Contains Thiamine, which helps the body to metabolise carbohydrates.

* Contains Thiamine, which is involved in the production of energy in the body.

* Contains Thiamine, which is essential for energy production n the body.

* Contains Riboflavin, which helps the body to metabolise proteins, carbohydrates and fats.

* Contains Riboflavin, which is involved in the metabolism of carbohydrates, proteins and fats in the body.

* Contains Nicotinamide (Niacin), which helps the body metabolise carbohydrates, fats and proteins.

* Contains Nicotinamide (Niacin), which is involved in the metabolism of carbohydrates, fats and proteins.

* Contains Pyridoxine (Vitamin B6), which helps to metabolise carbohydrates, proteins and fats in the body

* Contains Vitamin B12, which helps the body metabolise proteins, carbohydrates and fats.

* Contains Vitamin B12, which is involved n the production of energy in the body.

* Contains Pyridoxine (Vitamin B6), which is involved in more than 100 reactions affecting protein, lipid and

Public Summary

Page 2 of

Produced at 23.11.2017 at 07:43:28 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

carbohydrate metabolism.

* Contains Biotin, which is involved in fatty acid synthesis.

* Contains Nicotinamide (Niacin), which is involved in fatty acid, cholesterol and steroid hormone synthesis.

* Contains Nicotinamide (Niacin), which is a component of Glucose tolerance factor.

* 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.

* Vitamin B5 has a central role in adrenal function and cellular metabolism

* Pantothenic acid provides support to the nervous system.

* Pantothenic acid supports healthy nervous system function.

* Pantothenic acid supports the health and function of the nervous system.

* Contains Vitamin D, which supports the health and function of the nervous system.

* Contains Vitamin D, which supports neuromuscular function.

* Contains Vitamin D, which maintains muscle strength and has an effect in skeletal muscle and myocardial

function.

* Zinc is an essential trace mineral that is a component in over 200 enzymes in the body.

* Contains Maqnesium.which plays a necessary role in over 300 enzymatic reactions in the body.

* Magnesium is involved in over 300 essential metabolic reactions.

* Contains Nicotinamide (Niacin), which is involved in approximately 200 enzymes in the body.

* Contains Zinc, which helps support/maintain normal/healthy immune function.

* Contains Zinc, which is important for the health and function of the immune system.

* Contains Copper, which is involved in the development of mmune cells and immune function in the body.

* Iron is necessary for the normal function of the immune system.

* Contains Vitamin E, which supports normal/healthy immune system function.

* Contains Vitamin E, which supports the health and function of the immune system.

* Contains Vitamin D, which supports the health and function of the immune system.

* Vitamin C is essential for the proper function of the immune system.

* Contains Vitamin C, which supports a normal/healthy immune system.

* Contains Vitamin C, which plays a vital role in many immune mechanisms.

* Contains Vitamin C, which s nvolved in many immune mechanisms in the body and supports healthy immune

function.

* Contains Vitamin C, which supports healthy functioning of the immune system.

* Contains Riboflavin, which supports normal/healthy immune function.

* Contains Pyridoxine (Vitamin B6), which supports normal/healthy immune system function.

* Contains Pyridoxine (Vitamin B6), which is nvolved in immune system processes.

* Vitamin B12 is involved in mmune function.

* Vitamin B12 is involved in cellular immunity.

* Contains Zinc, which is involved in maintaining the structure and integrity of cell membranes.

* Contains Zinc, which helps to maintain healthy skin.

* Contains Nicotinamide (Niacin), which contributes to the maintenance of normal mucous membranes.

* Contains Nicotinamide (Niacin), which contributes to the maintenance of normal skin.

* Contains Biotin, which may support normal/healthy hair.

* Contains Biotin, which may support and maintain nail health.

* Contains Copper, which contributes to the production and maintenance of connective tissue.

* Contains Copper, which s an essential component in the synthesis of collagen.

* Copper is involved in the production of elastin and collagen.

* Contains Copper, which s involved in connective tissue formation.

* Contains Riboflavin, which is involved in tissue formation, such as hair, skin, nails and connective tissue.

* Contains Riboflavin, which is essential for tissue repair processes, such as general growth and healthy growth

of skin, nails and hair.

* Contains Riboflavin, which is essential for the maintenance of normal skin and mucous membranes.

* Contains Riboflavin, which contributes to normal skin and mucous membrane structure and function.

* Contains Zinc, which supports normal/healthy skin renewal processes.

* Contains Iodine, which plays a role in the maintenance of normal skin.

* Vitamin C is necessary for minor wound healing.

* Vitamin C is necessary for the maintenance of healthy skin.

* Vitamin C assists in the healing and repair of the skin

* Contains Riboflavin, which contributes to the maintenance of normal skin and mucous membranes.

* Contains Manganese, which is involved in the growth and maintenance of connective tissue and cartilage

* Contains Manganese, which is involved in normal bone growth and development.

* Contains Manganese, which is required for the synthesis of proteoglycans, an important structural component

of cartilage and bone.

* Contains Zinc, which is involved in antioxidant processes and may therefore assist in protecting the body from

the damaging effects of free radicals.

* Contains Zinc, which is a component of the antioxidant superoxide dismutase.

* Contains Zinc, which has antioxidant activity and may therefore assist in protecting the body from the damaging

effects of free radical damage.

* Selenium is an antioxidant nutrient

* Contains Manganese, which is a component of the antioxidant superoxide dismutase, and may therefore assist

in protecting the body from the effects of free radical damage.

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

* Copper is a component of the antioxidant super oxide dismutase (SOD).

* Contains Copper, which is a component of the antioxidant Super oxide dismutase (SOD).

* Contains Magnesium, which is required for the synthesis of the antioxidant glutathione.

* Contains Vitamin E, which is a fat-soluble antioxidant and may therefore assist in protecting the body from the

effects of free radical damage.

* Contains Vitamin E, which helps to protect the polyunsaturated fatty acids in cell membranes in the body from

free radical damage.

* Contains the antioxidant Vitamin E, which may assist n protecting the body from the effects of free radical

damage.

* Vitamin E has antioxidant activity.

* Contains Vitamin C, which is an important nutritional antioxidant/free radical scavenger.

* As an antioxidant, vitamin C assists in protecting the body from the damaging effects of free radicals.

* Vitamin C is a potent antioxidant that can reduce the risk of cellular damage from free radicals.

* Vitamin C can regenerate oxidized vitamin E in the body.

* Contains Riboflavin, which is an antioxidant and may assist in protecting the body from the effects of free

Public Summary

Page 3 of

Produced at 23.11.2017 at 07:43:28 AEDT

This is not an ARTG Certificate document.

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Visit www.tga.gov.au for contact information

radical damage.

* Contains Riboflavin, which is a component of glutathione reductase, an enzyme that helps provide antioxidant

protection in the eye.

* Contains Zinc, which supports normal/healthy eye function.

* Contains Zinc, which supports healthy vision and eye function.

* Zinc plays an important role in the visual system.

* Contains Riboflavin, which is a component of glutathione reductase, an enzyme that helps provide antioxidant

protection in the eye.

* Contains Zinc, which supports the health and function of the nervous system.

* Contains Copper, which is required for the formation of myelin.

* Contains Copper, which is involved in the normal transmission of nerve.

* Contains Copper, which is involved in the synthesis of some neurotransmitters, such as the synthesis of

norepinephrine from dopamine.

* Iron is a part of many enzymes that are involved with making new cells, amino acids, hormones, and

neurotransmitters.

* Iron is an essential cofactor in the synthesis of neurotransmitters such as dopamine, norepinephrine and

serotonin. * Iron s involved in the function and synthesis of neurotransmitters.

* Contains Vitamin C, which is involved in neurotransmitter synthesis.

* Contains Vitamin C, which contributes to normal neurological function.

* Contains Thiamine, which is involved in in the maintenance of nerve tissues in the body.

* Contains Thiamine, which plays a role in nerve function and transmission.

* Contains Thiamine, which supports normal/healthy nerve function.

* Contains Riboflavin, which contributes to the normal function of the nervous system.

* Contains Riboflavin, which contributes to the normal functioning of the nervous system.

* Contains Vitamin 812, which supports normal/healthy nervous system function

* Contains Vitamin 812, which s required for the synthesis of myelin, the insulation around nerves.

* Contains Vitamin 812, which is required for nerve myelination.

* Contains Magnesium, which plays a role in the body in neuromuscular transmission.

* Contains Magnesium, which plays a role in muscle contraction.

* Contains Thiamine, which supports normal/healthy muscle action.

* Contains Magnesium, which is necessary for proper muscle and nerve function.

* Contains Zinc, which plays a role in the maintenance of normal/healthy bone.

* Contains Magnesium, which is a constituent of bone.

* Contains Magnesium, which is necessary for teeth and bone structure.

* Contains Vitamin D, which is important for bone health.

* Contains Vitamin D, which helps to maintain serum calcium and phosphorus levels, which s critical for the

normal development of bones and teeth

* Contains Vitamin D, which supports the development and maintenance of strong, healthy bones.

* Contains Vitamin D, which supports healthy bone mineral density

* Contains Vitamin D, which supports/ helps maintain bone mineral density.

* Contains Vitamin D, which plays a role in calcium balance in the body.

* 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.

* Contains Selenium, which is an essential mineral in the selenium dependent enzyme that converts T 4 to T3.

* Contains Selenium, which is required for the conversion of thyroid hormone T4 to T3. These hormones control

a variety of biological and physiological processes in the body.

* Selenium plays a role in thyroid hormone production, which is required for normal thyroid function.

* Contains Iodine, which is an essential nutrient required for normal thyroid function.

* Contains Iodine, which is required for the synthesis of thyroid hormones T3 & T 4, which control a variety of

biological and physiological processes in the body.

* Contains Iodine, which is essential for the manufacture of the thyroid hormones T3 and T 4, which regulate

basal metabolism in the body.

* Contains Iodine, which is essential for the manufacture of thyroid hormones, which regulate cellular oxygen

consumption, basal metabolism and energy production throughout the body.

* Iodine dependent thyroid hormones regulate the basal rate of metabolism in the body.

* Iodine is essential for the manufacture of T3 and T 4, which are hormones that influence growth, thermogenesis

and the metabolism of all tissues.

* Contains Copper, which is involved in the absorption and metabolism of iron.

* Contains Vitamin C, which aids iron absorption.

* Copper is involved in iron metabolism.

* Copper contributes to normal iron transport in the body.

* Contains Riboflavin, which contributes to the normal metabolism of iron.

* Contains Riboflavin, which is involved in the maintenance of normal red blood cells.

* Contains Copper, which helps to form red blood cells.

* Contains Copper, which is involved in red blood cell production.

* Contains Copper, which is required for hemoglobin formation.

* Contains Iron, which helps to form and support the function of red blood cells.

* Contains Iron, which is involved in the transport of oxygen around the body.

* Contains Iron, which is involved in the transport of oxygen around the body by hemoglobin.

* Iron is an essential component of haemoglobin.

* Contains Vitamin C, which assists in maintaining a normal/healthy cardiovascular system.

* Contains Folic acid, which is involved in the formation of red blood cells.

* Contains Folic acid, which is involved in the healthy maturation of red blood cells.

* Contains Pyridoxine (Vitamin B6), which is involved in the formation of haemoglobin and the growth of red

blood cells.

* Contains Vitamin B12, which is required for red blood cell formation

* Contains Magnesium, which plays a role in proper muscle function, including the heart muscle.

* Contains Vitamin D, which is important for cardiovascular health.

* Supports normal/healthy cardiovascular function.

* Contains Folic acid, which is involved in homocysteine metabolism.

* Contains Pyridoxine (Vitamin 86), which supports normal/healthy cardiovascular function.

* Contains Pyridoxine (Vitamin 86), which is involved in homocysteine metabolism.

Public Summary

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Visit www.tga.gov.au for contact information

* Contains Vitamin 812, which supports normal/healthy cardiovascular function.

* Contains Magnesium, which helps to maintain normal electrolyte balance.

* Contains Magnesium, which is necessary for normal electrolyte balance.

* Contains Magnesium, which contributes to electrolyte balance.

* Contains Magnesium, which is an electrolyte.

* Contains the electrolyte Magnesium.

* Contains Vitamin D, which is mainly produced in our skin by a reaction that requires sunlight. People who limit

their exposure to sunlight may have an increased need for vitamin D supplementation.

* Vitamin C is involved in the normal breakdown of cholesterol into bile acids.

* Contains Pyridoxine (Vitamin 86), which is involved in hormone modulation.

* Contains Pyridoxine (Vitamin 86), which is involved in the regulation of hormonal activity.

Additional Product information

Container 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

85 mg

Biotin

.03 mg

Calcium pantothenate

6.65 mg

colecalciferol

.005 mg

Copper gluconate

7.15 mg

Cyanocobalamin

2.57 microgram

d-alpha-Tocopheryl acid succinate

18.7 mg

Ferrous fumarate

38 mg

Folic acid

500 microgram

Hydroxyapatite

153.85 mg

Magnesium oxide

165.84 mg

Manganese amino acid chelate

19 mg

Nicotinamide

18 mg

potassium iodide

330 microgram

pyridoxine hydrochloride

2.31 mg

Riboflavin

1.4 mg

Selenomethionine

125 microgram

Thiamine nitrate

1.73 mg

Zinc gluconate

85.28 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

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Produced at 23.11.2017 at 07:43:28 AEDT

This is not an ARTG Certificate document.

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Visit www.tga.gov.au for contact information

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