FOI 127-1314 document 24 part 5

)

)

Public Summary •l;!1Jitlm~iy.forcA~t~:E:n@:•·

~ -· .. _,- :: ., .. ,·· -; .,__ . -. ~ -~~,- .-.. """ ·-·-... '

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product cate_gory

Status

Approval area

179231 Swisse Men's Ultivite 65+ Multivitamin, Mineral and Antioxidant with Herbs

Medicine Listed

Swisse Wellness Pty Ltd

36-38 Gipps Street, COLLINGWOOD, VIC, 3066 Australia

18/01/2011

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Aust sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreemen kept.,

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and s to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request.,

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine i in relation to the inclusion of the medicine in the Register.,

All reports of adverse reactions or similar experiences associated with the use or ad minis! of Product Review, Therapeutic Goods Administration, as soon as practicable after the spons of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,

The sponsor shall not supply the listed medicine after the expiry date of the

Where a listed medicine is distributed overseas as well as in Aus outside Australia which has or may have relevance to the quality, Manager Therapeutic Goods Administration, immediately the

TGAeBS

be

The Ginkgo biloba leaf extract used in the manufacture of this Powdered Ginkgo Extract in the United States Pharm · 32 -

ent of Identification Test B of the monograph F27). This condition does not apply to powdered or

dried leaf.,

Colouring agents used in listed medicine for inge be only those included in the list of 'Colourings http://www.tga.gov.au/industry/cm-colou ·

Where the medicine is a convention the additional conditions are as foll this medicine must comply Tablets. Where the medicin dissolution requirements int Supplement. The dissolution shelf life of the product when sto the analytical m for the d apply to chewa

nly under section 25 of the Therapeutic Goods Act 1989, shall lea!

n, in tablet form, of strength of 100 micrograms or more per dosage unit, id as a single active ingredient, the dissolution characteristics for folic acid in

States Pharmacopoeia 24th Edition (USP24) monograph for Felic Acid lution characteristics for folic acid in this medicine must comply with the

4th Edition (USP24) monograph for Nutritional Supplements, as amended by its First ust comply with the dissolution requirements of the relevant USP24 monograph over the ed on the product label. It is the responsibility of manufacturers to develop and validate ould be used in conjunction with the USP24 dissolution criteria. This condition does not

ined release tablets.

Effective date 29/06/2012

nee if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.,

excess of 3000 micrograms retinol equivalents, vitamin A can cause birth defects.,

t 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.,

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

Do not take while on warfarin therapy without medical advice.

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

Helps maintain normal blood/blood tonic (Note: These claims are appropriate for folic acid, vitamin 812 and iron, but must not imply anaemic conditions),

May assist in maintaining peripheral circulation and promoting general health.,

For mineral (may state the mineral) supplementation.,

of3 Produced at 13.03.2014 at 02:36:09 EST 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

)

)

TGAeBS

For vitamin (may state the vitamin) supplementation.,

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).,

May assist in the management of dietary folate deficiency.,

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

a comprehensive formula containing premium quality vitamins, minerals, herbs and antioxidants designed to support the specific nutritional needs and health concerns of men over the age of 65. includes over 40 essential vitamins, minerals, herbs and antioxidants to supplement the diet and support the body's nutritional m~eds. includes high levels of B vitamins to help support energy production ... or 1 OOOIU of natural vitamin 03 per tablet to assist the absorption of calcium and help maintain healthy bone density. contains antioxidants such as Knotweed, a source of resveratrol, and grape seed to protect cells against free radical damage. i tribulus to promote stamina and help support male health in those over 65 years of age. may help to maintain healthy homocysteine levels. provides support for the nervous system.

1. Formulation 1

Dosage Form

Route of Administration

Visual Identification

Active 11\greWents.

Biotin

Calcium ascorbate dihydrate

Calcium orotate

Calcium pantothenate

Cholecalciferol

Chromium picolinate

Citrus bioflavonoids extract

Copper gluconate

Crataegus monogyna

Equivalent: Crataegus monogyna (

Cyanocobalamin

Cynara scolymus

hosphatidylserine-enriched soy

Magnesium aspartate dihydrate

Manganese amino acid chelate

Molybdenum trioxide

Nicotinamide

Phytomenadione

Potassium iodide

Pyridoxine hydrochloride

Retinyl acetate

Riboflavin

of3 This is not an ARTG Certificate document.

Poison Schedule

100 mg

109.15 mg

.025mg

402.3 microgram

20mg

12.14mg

30mg

120 mg

200 microgram

1 mg

50mg

25mg

20mg

200 mg

BO mg

Bg

16.01 mg

500 microgram

20mg

1 g

10mg

1 mg

100 mg

40mg

67.5 microgram

100 mg

70 microgram

196 microgram

50 mg

.8625mg

50mg

Produced at 13.03.2014 at 02:36:09 EST

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

)

Scutellaria lateriflora

Equivalent: Scutellaria lateriflora (Dry)

Selenomethionine

Serenoa repens

Equivalent: Serenoa repens (Dry)

Silybum marianum

Equivalent: Silybum marianum (Dry)

Spearmint Oil

Thiamlne,hydrochloride

Tribulus terrestris

Equivalent: Tribulus terrestris (Dry)

Tribulus terrestris


Ubidecarenone

Urtica dioica

Equivalent: Urtica dioica (Dry)

Vaccinium macrocarpon

Equivalent: Vaccinium macrocarpon (Fresh)

Vaccinium myrtillus

Equivalent: Vaccinium myrtillus (Fresh)

Vitis vinifera

Equivalent: Vitis vinifera (Dry)

Zinc amino acid chelate

©Commonwealth of Australia.This work is copyright.You are not per

written approval from the Commonwealth.Further details can be i

of3 This is not an ARTG Certificate document.

12.Smg

50mg

TGAeBS

124.2 microgram

75mg

300 mg

24.29mg

1.7 g

2mg

50mg

10mg

500 mg

10mg

cialise the material without obtaining prior

e-copyright.htm.



TGAeBS

Public Summary . su'l1!1i~cy f91'~~1'G·!\')1.tfy; .. ·.

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

188269 Swisse Ultiboost Odourless Wild Fish Oil

Medicine Listed

Swisse Wellness Ply Ltd


19/08/2011

Medicine

Revoked

Listed Medicines


The sponsor shall retain records of the distribution of the listed mediciae for a period offive years and s to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request.,

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine 1i in relation to the inclusion of the medicine in the Register.,

All reports of adverse reactions or similar experiences associated with the use or administ of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponso of listed medicines must retain records of such reports for a period of not less than 18 months fro of the report or reports.,

The sponsor shall not supply the listed medicine after the expiry date of the.

Where a listed medicine is distributed overseas as well as in Aust outside Australia which has or may have relevance to the quality, Manager Therapeutic <;>cods Administration, immediately the a

I be

Colouring agents used in listed medicine for ingestion, other ction 25 of the Therapeutic Goods Act 1989, shall be only those included in the list of 'Colourings permit! · http://www.tga.gov.au/industry/cm-colourings-oral-

e Swiss swim freely Swisse Ultiboost flavour.

29/06/2012

eneral good health and are especially beneficial for the heart, brain, joints and eyes. cids may play an important role in helping maintain a healthy cardiovascular system by supporting normal erol in healthy individuals.

in the central nervous system found in the walls of brain cells and is important for the natural repair process. eficial for joint health and are vital for vision. They play a structural and functional role in the retina and nerve cells of the

Wild Fish Oil contains premium ingredients. It contains omega-3 fatty acids, EPA and DHA and is sourced from wild fish that Ocean ± 'sustainable free range fish'.

dourless Wild Fish Oil capsules are completely free from 'fishy' taste or smell and contain added natural spearmint oil and vanilla

Based on 25+ years research. You'll feel better on Swisse. Does not contain artificial chemicals such as polysorbate to reduce the reflux action and fishy after taste.

Type

Jar/Can

Page 1 of2

Material

Not recorded

Life Time

Not recorded

This is not an ARTG Certificate document.

Temperature

Not recorded

Closure

Not recorded

Conditions

Not recorded



)

Paek $iz~t~~iliO:ni11fO:rma.tion •

Pack Size

1. Formulation 1

Dosage Form



Attive·lngredi.eitts

Fish oil - natural

Poison Schedule

Capsule, soft

Oral

1000 mg

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise th.e mate

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copy tm.

TGAeBS

Page 2 of2 Produced at 13.03.2014 at 02:39:40 EST 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

)

Public Summary ~~tl'i!J'l~ry'fot~tq ~lltij~ ' · •. ·. 187006 Swisse Ultiboost Prostate

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



29/07/2011

Medicine

Revoked

Listed Medicines

TGAeBS

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Th.~ .• be only those included in the list of 'Colourings permitted in medicines for oral use' available at · · http://www.tga.gov.auflndustry/cm-colourings-oral-use.htm,as amended from time to time.,

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distribut Manager Therapeutic Goods Administration, immediately the action or information is known to the spo

The sponsor shall not supply the listed medicine after the expiry date of the goods.,

All reports of adverse reactions or similar experiences associated with the use or administ of Product Review, Therapeutic Goods Administration, as soon as practicable after the s of listed medicines must retain records of such reports for a period of not less than 18 mont of the report or reports.,

The sponsor of the listed medicine must not, by any means, intentionally or in relation to the inclusion of the medicine in the Register.,

The sponsor shall retain records of the distribution of the listed medi to the Office of Complementary Medicines, Therapeutic Goods

e the records or copies of the records

th of 100 micrograms or more per dosage unit, ient, the dissolution characteristics for folic acid in

4th Edition (USP24) monograph for Folic Acid ics for folic acid in this medicine must comply with the

for Nutritional Supplements, as amended by its First

Where the medicine is a conventional release folic acid sup the additional conditions are as follows: Where the medicin this medicine must comply with the dissolution require Tablets. Where the medicine contains multiple ac · dissolution requirements in the United States Pha Supplement. The dissolution characteristics for t shelf life of the product when stored under the c the analytical methods for the determinati f i

n requirements of the relevant USP24 monograph over the It is the responsibility of manufacturers to develop and validate

ction with the USP24 dissolution criteria. This condition does not apply to chewable, effervescent or dis

The sponsor shall keep records relati {b} Identify the manufacturer(s f ea sub-contracted to a third pa kept.

ry to: (a) Expedite recall if necessary of any batch of the listed medicine, e any part of or step in manufacture in Australia of the listed medicine is

t Good Manufacturing Practice agreements relation to such manufacture shall be



For the symptomatic reliM of medically diagnosed benign prostatic hypertrophy.

Swisse Ultiboost Prostate is based on over 25 years of research and contains premium quality ingredients to assist in normal prostate function. Certain ingredients in the formula may provide relief from the symptoms of medically diagnosed Benign Prostatic Hypertrophy (or Hyperplasia, commonly known as prostate enlargement), including difficulties in micturition, a hesitant interrupted weak stream, urinary frequency, urgency and dribbling or leaking.


)

Pack~i;i:~/Pgi~.on jllfgrfoatioll ,

Pack Size

qC>U1P,9p~pt§, .. 1. Formulation 1

Dosage Form



Active lngrediliots

Cholecalciferol

Cucurbita pepo

Equivalent: Cucurbita pepo (Dry)

Curcuma longa

Folicacid

Ganoderma lucidum

Equivalent: Ganoderma lucidum (Dry)

Glycyrrhiza glabra

Equivalent: Glycyrrhiza glabra (Dry)

lsatis tinctoria

Equivalent: lsatis tinctoria (Dry)

Lycopersicon esculentum

Panax ginseng

Equivalent: Panax ginseng (Dry)

Selenomethionine

Serenoa repens


Serenoa repens


Urtica dioica



written approval from the Comm

Page 2 of2 This is not an ARTG Certificate document.

Poison Schedule

Tablet, film coated

Oral

TGAeBS

1.25 microgram

100 mg

1 g

62.5 mg

1 g

30mg

transmit, distribute or commercialise the material without obtaining prior

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



_)

)

Public Summary :8~!1'1\h~ry·f~~M!~¥~t.Y: .\ .· 186097 Swisse Magnesium

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



30/06/2011

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Austra

TGAeBS

sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreemen lation to kept.,


The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine in relation to the inclusion of the medicine in the Register.,

All reports of adverse reactions or similar experiences associated with the use or adminis of Product Review, Therapeutic Goods Administration, as soon as practicable after the spans of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,


Where a listed medicine is distributed overseas as well as in Aus outside Australia which has or may have relevance to the quality, Manager Therapeutic Goods Administration, immediately the a

be

Colouring agents used in listed medicine for ingestion, other a be only those included in the list of 'Colourings permit! · http://www.tga.gov.au/industry/cm-colourings-oral-u

ction 25 of the Therapeutic Goods Act 1989, shall

Dosage Form



MtlveJflgr~cl!E!~~···.

Magnesium citrate

29/06/2012

is inadequate. OR Vitamin supplements should not replace a balanced diet.

Poison Schedule

Tablet, film coated

Oral

927.64mg

©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.

Page 1of1 Produced at 13.03.2014 at 02:38:42 EST 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

)

Public Summary s1,1wro~rYJc:>r~TG i;;n!ry:

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

181937 Swisse Professional Green Tea Extract

Medicine Listed



7/04/2011

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of a (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Aust sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreemen kept.,

The sponsor shall retain records of the distribu\ion of the listed medicine for a period of five years and s to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request.,

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine fo in relation to the inclusion of the medicine in the Register.,

All reports of adverse reactions or similar experiences associated with the use or administ of Product Review, Therapeutic Goods Administration, as soon as practicable after the spons of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,



TGAeBS

be

Colouring agents used in listed medicine for ingestion, other be only those included in the list of 'Colourings permit! http://www.tga.gov.au/industry/cm-colourings-oral-u


29/06/2012

per gram of product] [must be clear and legible].

tract with potent antioxidant properties to support the cardiovascular system and maintain a healthy

attributed to atechins, for which

extract in Swisse ised to ensure the for antioxidant defence

.ea uses young tea leaves, ested at selected times to target

erapeutically active components within the plant. Green e of antioxidant catechins. Antioxidants defend against free radical damage.

Pack Size

1. Formulation 1

Dosage Form



Poison Schedule

Tablet, film coated

Oral



)


Active Ingredients

Camellia sinensis

Equivalent: Camellia sinensis (Dry)

972 mg

24.3g

TGAeBS


written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm. ,,


)

TGAeBS

Public Summary .~ll!!im~fof,Mt9:E'!V:J:

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Stat~s Approval area

186092 Swisse Calcium +Vitamin D

Medicine Listed



30/06/2011

Medicine

Revoked

Listed Medicines


Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory acli outside Australia which has or may have relevance to the quality, safely or efficacy of the goods distributed in Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Colouring agents used in listed medicine for ingestion, other than those listed for export·only under sec be only those included in the list of 'Colourings permitted in medicines for oral use' available at http://www.tga.gov.auflndustry/cm-colourings-oral-use.hlm,as amended from time to time.,

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing kept.,

The sponsor shall retain records of the distribution of the listed medicine for a to the Office of Complementary Medicines, Therapeutic Goods Administrati

al

The sponsor of the listed medicine must not, by any means, intention 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 assoc· of Product Review, Therapeutic Goods Administration, as soon of listed medicines must retain records of such reports perio of the report or reports. ·

medicine shall be notified to the Head, Office goods becomes aware of those reports. Sponsors

the day the Head, Office of Product Review is notified

29/06/2012


Dosage Form·



· A~tly~ lngre<1fe11t!S .

Calcium citrate

Cholecalciferol


Poison Schedule

Tablet, film coated

Oral

1.579 g

.0083mg



,,

)

TGAeBS


written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/abouVwebsite-copyright.htm.


)

Public Summary $,u.iJlm#J1:1rMTl3·~~ti;y:.

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

193883 Swisse Practitioner Yeast Response

Medicine Listed



17/01/2012

Medicine

Revoked

Listed Medicines

The sponsor shall retain records of the distribution of the listed medicine for a period offive years and shall provide the L to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request., ...

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if ne (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufact sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice kept.,

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine ~ in relation to the inclusion of the medicine in the Register.,

Colouring agents used in listed medicine for ingestion, other than those listed for export o ·· be only those included in the list of 'Colourings permitted in medicines for oral use' available at http://www.tga.gov.au/industry/cm-colourings-oral-use.htm,as amended from time to time.,

TGAeBS

be

in relation to the medicine Where a listed medicine is distributed overseas as well as in Australia, prod outside Australia which has or may have relevance to the quality, safety or Manager Therapeutic Goods Administration, immediately the action or infor

, must be notified to the National

The sponsor shall not supply the listed medicine after the expiry d

All reports of adverse reactions or similar experiences asso medicine shall be notified to the Head, Office e goods becomes aware of those reports. Sponsors

the day the Head, Office of Product Review is notified of Product Review, Therapeutic Goods Administration, as soon of listed medicines must retain records of such reports of the report or reports.

Dosage Form



Ac;tive Ingredients

Page 1 of2

19/01/2012 3:07:27 PM


uality herbal and nutritional formula which provides support in the maintenance of normal intestinal e and supports the integrity of the digestive lining.

e attributed to golden seal, Pau D'arco, Oregon grape and calendula, which have traditionally been used

lement any loss of natural biotin production due to microflora imbalance. · ional Western herbal medicine may help protect against fungal and other microbial infections.

Response have been traditionally used in the herbal medicine of the Americas for fighting infections. The herbs have been traditionally used for their beneficial effect on the body's mucous membranes and digestive ability to

Poison Schedule

Tablet, film coated

Oral

Produced at 13.03.2014 at 02:41 :49 EST 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

.. ~ '

Barberis aquifolium

Equivalent: Barberis aquifolium (Dry)

Biotin

Calendula officinalis

Equivalent: Calendula officinalis (Dry)

Hydrastis canadensis

Equivalent: Hydrastis canadensis (Dry)

Tabebuia avellanedae

Equivalent: Tabebuia avellanedae (Dry)


150 mg

600 mg

33.33 mg

250 mg

1 g

83.33 mg

333.32 mg

208.33 mg

833.32 mg

16.67mg

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the mate

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyr

TGAeBS


Public Summary · ~HQl~~~}pt~Tg'~6@: ;.· · · · · ·

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

169265 Swisse Ultiboost Super C

Medicine Listed



19/02/2010

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Aust sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreeme kept.,



All reports of adverse reactions or similar experiences associated with the use or adminis of Product Review, Therapeutic Goods Administration, as soon as practicable after the spans of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,



TGAeBS

be

Colouring agents used in listed medicine for ingestion, other be only those included in the list of 'Colourings permit! http://www.tga.gov.au/industry/cm-colourings-oral-u


29/06/2012

e is inadequate. OR Vitamin supplements should not replace a balanced diet.,

ords to that effect).,

on the assessment of clinical studies and incorporate highest grade, scientifically validated ingredients which have

uper C is based on 25 years of research and contains scientifically validated ingredients to help reduce the severity and port the body?s normal resistance to colds and flu. Vitamin C is a potent antioxidant which can help reduce the risk of cell

damage fr s. Vitamin C also helps to enhance the absorption of dietary iron and may help promote skin health and wound healing because of its involvement in the manufacture of collagen. Swisse Ultiboost Super C is derived from non acidic calcium ascorbate making it gentle on the stomach. -antioxidant, helps to reduce free radical damage -may help to boost your immune system -traditionally, vitamin c may help to reduce histamine levels, helping in the management of some allergies - vitamin c may help improve normal, healthy immune function - vitamin c is water soluble and is not stored in the body, therefore regular/daily intake is desirable

Type Material Life Time Temperature Closure Conditions

Page 1 of2 Produced at 13.03.2014 at 02:29:21 EST This is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of the infonTlation on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

)

Jar/Can Not recorded Not recorded Not recorded Not recorded

·p-a-c:~ ~t~ef P,~J-~9.i:i'X!1t~fi:li~!i§fl . • · • . .. Pack Size Poison Schedule

:~~·WDR·~~}i!~;~~ _.:· c·o .- -.· .-·-·-··-

1. Formulation 1

Dosage Form



Ac.tiv.e lngredient5


Ubidecarenone

Tablet, film coated

Oral

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or comme

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/abouUwe

1.2478 g

TGAeBS

Not recorded


)

TGAeBS

Public Summary &~tritJi;ii}tfRtAJ'~f~t~iJtiX:, , •.

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

174560 Swisse Ultiboost Wild Fish Oil

Medicine Listed



5/08/2010

Medicine

Revoked

Listed Medicines

.:S




All reports of adverse reactions or similar experiences associated with the use or ad minis of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponso of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,

The sponsor shall not supply the listed medicine after the expiry date of the.

Where a listed medicine is distributed overseas as well as in Aust outside Australia which has or may have relevance to the quality, Manager Therapeutic Goods Administration, immediately the a

I be

Colouring agents used in listed medicine for ingestion, othe lion 25 of the Therapeutic Goods Act 1989, shall be only those included in the list of 'Colourings permit! · medi http://www.tga.gov.aunndustry/cm-colourings-o

29/06/2012

· general good health and are especially beneficial for the heart, brain, joints and eyes. y acids may play an important role in helping maintain a healthy cardiovascular system by supporting normal

holesterol in healthy individuals. acid in the central nervous system found in the walls of brain cells and is important for the natural repair process.

e beneficial for joint health and are vital for vision. They play a structural and functional role in the retina and nerve cells of the eye. Swisse Ulti Fish Oil contains premium ingredients. It contains omega-3 fatty acids, EPA and DHA and is sourced from wild fish that swim freely in the Pacific Ocean± 'sustainable free range fish'. you'll feel better on swisse Based on 25+ years research

Poison Schedule

Page 1 of2 Produced at 13.03.2014 at 02:30:29 EST 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. Visitwww.tga.gov.au for contact information

)

Dosage Form



Active lngreifieJ1ts

Fish oil - natural

Capsule, soft

Oral

1000 mg

TGAeBS

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without.obtaining prior



)

J

Public Summary ~vMrfl~.~'°'tNtt~~iJtiy: i'' 169764 Swisse Ultiboost Executive Focus

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status/,

Approval area

Medicine Listed


36-38 Gipps Street, COLLINGWOOD, v·1c, 3066 Australia

11/03/2010

Medicine

Revoked

Listed Medicines

TGAeBS

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of a (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreement ion t be kept.,

The sponsor shall retain records of the distribution of the listed medicine for a period offive years and s to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request.,


All reports of adverse reactions or similar experiences associated with the use or adminis of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponso · of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,



The Ginkgo biloba leaf extract used in the manufacture of this Powdered Ginkgo Extract in the United States Pharma · 32 -dried leaf.,

ment of Identification Test B of the monograph F27). This condition does not apply to powdered or

Colouring agents used in listed medicine for ing be only those included in the list of 'Colourings http://www.tga.gov.au/industry/cm-colou

under section 25 of the Therapeutic Goods Act 1989, shall !eat


US is based on 25 years of research and contains scientifically validated ingredients to assist in memory function and UTIVE FOCUS is based on the assessment of clinical studies that show certain ingredients in the formula can improve

e mental alertness, help to relieve anxiety and stress. Swisse Ultiboost EXECUTIVE FOCUS helps to improve brain functions !ration. Used as directed, Swisse Ultiboost EXECUTIVE FOCUS may deliver positive results relatively quickly.

If you s al conditions, please consult your health care professional for advice on the suitability of this product for you. Use only as directed and see 'your health care professional if symptoms persist. Vitamin supplements should not replace a balanced diet.

Type

Jar/Can

Pack Size

Page 1 of2

Material

Not recorded

Life Time

Not recorded


Temperature

Not recorded

Poison Schedule

Closure

Not recorded

Conditions

Not recorded



)

)

G!>n'i!l!:>~~~ts .: 1. Formulation 1

Dosage Form



Active Ingredients

Bacopa monnieri


Cyanocobalamin

Ginkgo biloba

Equivalent: Ginkgo biloba (Dry)

Nicotinamide


Riboflavin

Thiamine

Tablet, film coated

Oral

186.66 mg

70mg

25 microgram

60mg

3g

TGAeBS

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribu ··or commerci written approval from the Commonwealth.Further details can be found at http://www.tga.gov

Page 2 of2 Produced at 13.03.2014 at 02:30:02 EST 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 dale shown. Visit www.tga.gov.au for contact information

)

TGAeBS

Public Summary $11ri,Jfoaiy,t~( ~J~cE:h,try: ···

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status·

Approval area

169032 Swisse Women's Green Ultivite

Medicine Listed



12/02/2010

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of a (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Austr sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreement kept.,


The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine i in relation to the inclusion of the medicine in the Register., ·



Where a listed medicine is distributed overseas as well as in Australi outside Australia which has or may have relevance to the quality, Manager Therapeutic Goods Administration, immediately the a

I be

Colouring agents used in listed medicine for ingestion, other a be only those included in the list of 'Colourings permit!

tion 25 of the Therapeutic Goods Act 1989, shall

http://www.tga.gov.auflndustry/cm-colouring

1. Formulation 1

Dosage Form



,4.ctive lrigreclients .

Arthrospira platensis

Camellia sinensis


Poison Schedule

Tablet, film coated

Oral

29/06/2012

500 mg

6.25mg



)

Mentha X piperita 20 mg

Olea europaea 10mg

Equivalent: Olea europaea (Dry) 100 mg

Punica granatum 2mg

Equivalent: Punica granatum (Dry) 100 mg

Silybum marianum 14.29 mg

Equivalent: Silybum marianum (Dry) 1000 mg

Vitex agnus-castus 10 mg

Equivalent: Vitex agnus-castus (Dry) 100 mg

Withania somnifera 10mg

Equivalent: Withania somnifera (Dry) 100 mg

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercia

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-

TGAeBS


_)

Public Summary · §~~!Jl;;iij fC!tART~t:ntl'Y,: :

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

169030 Swisse Ultiboost Calcium + Vitamin D

Medicine listed



12/02/2010

Medicine

Revoked

listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of a (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Austr sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreemen kept.,



All reports of adverse reactions or similar experiences associated with the use or administ of Product Review, Therapeutic Goods Administration,. as soon as practicable after the spons of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,


Where a listed medicine is distributed overseas as well as in Austral outside Australia which has or may have relevance to the quality, Manager Therapeutic Goods Administration, immediately the a

TGAeBS

be

Colouring agents used in listed medicine for ingestion, other ction 25 of the Therapeutic Goods Act 1989, shall be only those included in the list of 'Colourings permi · http://www.tga.gov.au/industry/cm-colourings-oral-u

29/06/2012


re increased after menopause. Calcium supplementation may be of assistance in the prevention

intent) and a diet deficient in calcium can lead to osteoporosis in later life,

ents are increased after menopause.,

plement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium h13n bone and tissue for children and older adults.,

calcium in our youth and throughout life is required to maximise bone.,

prevention and/or treatment of osteoporosis.

Vitamin 03 and calcium supplement for when these vitamins/minerals are lacking in the diet Vitamin D supplementation may assist in regulation.of calcium metbolism and bone mineralization in those not obtaining sufficient vitamin D due to diet or lifestyle factors Vitamin D promotes the body?s absorption of calcium, important to maintain healthy bones and teeth A supplement to aid in the management of calcium deficiency states Helps maintain healthy bones and teeth Calcium requirements may be increased with age, gender, diet, pregnancy and laction ? provides supplemental calcium Women?s calcium needs are increased after menopause Formulated using the citrate form of calcium, shown to have a higher bioavailability than other forms of calcium Patented black pepper extract (piper nigrum) Bioperine contains active ingredient piperine, shown to help increase nutrient uptake


)

)

Pack Size

~~filp~ij~:rit~ ,c 1. Formulation 1

Dosage Form



A~tiv~ lngr~dients

Calcium citrate

Cholecalciferol

Piper nigrum

Equivalent: Piper nigrum (Dry)

Poison Schedule

Tablet, film coated

Oral

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or com


1.5798 g

.0083mg

TGAeBS


)

)

Public Summary ··~liJ11.i1l~rfJ<>tM\~;~11trl!;< .

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status·

Approval area

168788 Swisse Ultiboost Sports

Medicine Listed



4/02/2010

Medicine

Revoked

Listed Medicines







TGAeBS

be

Colouring agents used in listed medicine for ingestion, other t ction 25 of the Therapeutic Goods Act 1989, shall be only those included in the list of 'Colourings permitt · http://www.tga.gov.au/industry/cm-colourings

Dosage Form



Active Ingredients

Page 1 of2

29/06/2012

fatty acids into the energy producing units in cells, the mitochondria. concentrations in the mitochondria and as a result, reduced energy production.

y source. Therefore, 1-carnitine may be beneficial for a variety of conditions associated with

e associated with impairment of muscle function s a p ysical rejuvenation tonic. It may help maintain general wellbeing and physical vitality for both men and women, em tonic herb during times of stress. a and Russia dates back several thousands of years. Traditionally it has been used to help the body adapt when

herb traditionally used as a tonic to support the body during periods of exertion. Also useful during convalescence

Poison Schedule

Tablet, film coated

Oral

Produced at 13.03.2014 at 02:28:02 EST 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

)

Eleutherococcus senticosus

Equivalent: Eleutherococcus senticosus (Dry)

Levocarnitine

Tribulus terrestris

Equivalent: Tribulus terrestris (Fresh)

Tribulus terrestris


16.67 mg

250 mg

500 mg

25mg

1.25g

25mg

1.25 g

TGAeBS

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material wit



)

.J

TGAeBS

Public Summary ~!lmllJafy;t~tMl'~·~~il'Y: ,

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

168781 Swisse Ultiboost Glucosamine +

Medicine Listed



4/02/2010

Medicine

Revoked

Listed Medicines



The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine fa in relation to the inclusion of the medicine in the Register.,

All reports of adverse reactions or similar experiences associated with the use or adminis of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponso of listed medicines must retain records of such reports for a period of not less than 18 months fro of the report or reports.,

The sponsor shall not supply the listed medicine after the i:ixpiry date of the

Where a listed medicine is distributed overseas as well as in Aust outside Australia which has or may· have relevance to the quality, Manager Therapeutic Goods Administration, immediately the a

I be

Colouring agents used in listed medicine for ingestion, other be only those included in the list of 'Colourings permit! http://www.tga.gov.au/industry/cm-colourings-o


Product Type

Derived from seafood.,

Type

Jar/Can

Pack Size

Dosage Form

Page 1 of2

Material

Not recorded

. 29/06/2012

en used in traditional Chinese and Ayurvedic medicine for thousands of years for its anti-inflammatory properties, nutritents to the joints

Life Time

Not recorded

Temperature

Not recorded

Poison Schedule

Tablet, film coated

Closure

Not recorded

Conditions

Not recorded


)

)



Active Ingredients

Glucosamine sulfate-sodium chloride complex

Zingiber officinale

Equivalent: Zingiber officinale (Fresh)

Oral

1.8858 g

25mg

500 mg

TGAeBS

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material withoutpbtaining prior



TGAeBS

Public Summary $q~Jil~iyJor'A~ti,;.i;;nt;y: i •

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

168786 Swisse Ultiboost Complete Natural Vitamin E

Medicine Listed



4/02/2010

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Aust sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreem ation t kept.,

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and sha to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request.,

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine~ in relation to the inclusion of the medicine in the Register.,




I be

Colouring agents used in listed medicine for ingestion, other tha be only those included in the list of 'Colourings permi · di

ion 25 of the Therapeutic Goods Act 1989, shall

http://www.tga.gov.au/industry/cm-colourings-oral-

Type

Jar/Can

1. Formulation 1

Page 1 of2

29/06/2012

e is inadequate. OR Vitamin supplements should not replace a balanced diet.

al Vitamin E contains premium quality ingredients to help support heart health and circulation. Swisse Ultiboost · s natural vitamin E which is retained for a longer period in the blood compared to

rts heart health and assists with blood circulation. It also acts as an antioxidant to protect cells from potential free

Material Closure

Not recorded

Life Time

Not recorded

Temperature

Not recorded Not recorded

Conditions

Not recorded

Poison Schedule


)

Dosage Form



Active.lngred!erit~

d-alpha-Tocopherol

Tocotrienols complex - palm

Capsule, soft

Oral

335.6 mg

2mg

TGAeBS


written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/abouVwebsite-copyright.htm. A?J'!f:: Jl;;f!/-"'


)

)

Public Summary SCimmiifY fllr;;~Rtt3 Enuy: •. ---· - "''""-·""' ... ,,_:·:._.·_--_ . -:····-- :.--

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

175898 Swisse Ultiboost Appetite Suppressant

Medicine Listed



17/09/2010

Medicine

Revoked

Listed Medicines




All reports of adverse reactions or similar experiences associated with the use or administ of Product Review, Therapeutic Goods Administration, as soon as practicable after the spans of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,



TGAeBS

be

Colouring agents used in listed medicine for ingestion, other t be only those included in the list of 'Colourings permit! http://www.tga.gov.au/industry/cm-colourings-oral-


Pack Size

1. Formulation 1

Dosage Form



Activeinwedients

Caralluma adscendens var. fimbriata

Page 1 of2

4/04/2013

individuals e, based on traditional evidence.

is an edible plant used for centuries in India as a famine food and appetite suppressant. er India.

the cactus when hunting or embarking on a long journey as it can suppress the appetite for several hours. eight loss product.

Poison Schedule

Tablet, film coated

Oral

500 mg


)

TGAeBS

Equivalent: Caralluma adscendens var. fimbriata (Dry) 6g




)

Public Summary S\IT!)'.!'ilrfl~Mrtt~'.~nt[Y: • .·· 175334 Swisse Ultiboost Inner Balance

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



2/09/2010

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Aust sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreement kept.,



All reports of adverse reactions or similar experiences associated with the use or administ of Product Review, Therapeutic Goods Administration, as soon as practicable after the spans of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports., ·



TGAeBS

be

Colouring agents used in listed medicine for ingestion, other tion 25 of the Therapeutic Goods Act 1989, shall be only those included in the list of 'Colourings permit! · http://www.tga.gov.au/industry/cm-colourings-oral-u

} atural defenses

s defenses } {function}

29/06/2012

tural killer cell activity, a critical component of the natural immune function.

healthy {cultures} {bacteria} {flora} I microflora

o GI pathogens, known risk factors in human disease e function

· Helps main icrobial balance that is associated with good digestive health · Helps maintain a healthy digestive system ·Aids in the digestion of dairy products Swisse Ultiboost Inner Balance contains premium quality probiotic strains to help support intestinal health, digestive function and inner wellbeing. Probiotics are friendly bacteria that live naturally in the gut. Studies show that probiotics help maintain a balanced intestinal and digestive environment, which results in healthy digestion, regular bowel function and general wellbeing. Swisse Ultiboost Inner Balance contains Danisco HOWARU® bifido, a clinically tested strain of probiotic scientifically shown to strengthen the body's natural defences and help support a healthy immune system. HOWARU® bifido has been carefully selected for its ability to survive the digestive processes. If you have been taking a course of antibiotics, friendly bacteria levels in the digestive system may be disrupted. Swisse Ultiboost Inner Balance can balance levels of friendly bacteria that may have been interrupted due to antibiotic use. Probiotics are sensitive to temperature. Swisse Ultiboost Inner Balance should be refrigerated to ensure stability and potency.




) ·'

Dosage Form



~ctiVe Ingredients

Bifidobacterium lactis

Bifidobacterium lactis

Lactobacillus acidophilus

Poison Schedule

Capsule, hard

Oral


written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/abouVwebsite-

TGAeBS

8.335 mg

Page 2 of 2 Produced at 13.03.2014 at 02:34:25 EST 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

)

TGAeBS

Public Summary ·~YIT@l'i:Yif~t~t~~l1!rY,f .

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

174637 Swisse Pregnancy+ Ultivite

Medicine Listed



7/08/2010

Medicine

Revoked

Listed Medicines




All reports of adverse reactions or similar experiences associated with the use or administ of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponso of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,


Where a listed medicine is distributed overseas as well as in Aus outside Australia which has or may have relevance to the quality, Manager Therapeutic Goods Administration, immediately the

lbe

Colouring agents used in listed medicine for ingestion, other be only those included in the list of 'Colourings permit! ·

lion 25 of the Therapeutic Goods Act 1989, shall

http://www.tga.gov.au/industry/cm-colourings-

Product Type 29/06/2012

Not for the treatment of iro

daily dose of 150 micrograms for adults of selenium from dietary supplements should not

s premium quality ingredients to provide nutritional support for mother and baby during preconception, pregnancy a One omega-3 DHA supplement designed to safeguard nutritional intake and the increased physiological demands on the mot ncy. The bene ega-3 DHA during pregnancy have been well researched, as the growing baby relies solely on supplies from the mother. Omega-3 DHA ys an essential role in the healthy development of the brain, nervous system and eyes in the foetus and newborn. Includes iodine to promote baby's healthy brain development during pregnancy and lactation. Swisse Pregnancy+ Ultivite also contains the recommended amount of folic acid, which may reduce the risk of birth defects such as spina bifida. Felic acid is needed for the synthesis of DNA and is important in periods of rapid cell growth. B vitamins help to support increased energy requirements during pregnancy. Iron helps to address increased needs during pregnancy, maintain healthy blood and assist in the formation of haemoglobin, the oxygen carrier in red blood cells. Natural vitamin D has helps to aid the absorption of calcium which is vital for the development of bones and teeth.

Poison Schedule


.··)

1. Formulation 1

Dosage Form



~ctivll lngredi!l:Ots

Arthrospira platensis

Biotin

Calcium citrate


Cholecalciferol

Chromium picolinate

Copper gluconate

Cyanocobalamin

d-alpha-Tocopherol

Dunaliella salina

Fish oil - natural

Folic acid

Iron amino acid chelate

Magnesium amino acid chelate

Molybdenum trioxide

Nicotinamide

Phytomenadione

Potassium iodide


Riboflavin

Selenomethionine

Sodium ascorbate

Thiamine nitrate

Vitis vin ifera



© Commonwealth of Australia.


Capsule, soft

Oral

100 mg

30 microgram

94.79 mg

5mg

TGAeBS

161.5 microgram

67.5mg

1.4mg

7.46 mg

895.2 mg

55mg

not permitted to re-transmit, distribute or commercialise the material without obtaining prior

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



)

)

Public Summary Mmw!i:YJor:~'r~~~ti1':<' · 114630 Swisse Ultiboost High Strength Wild Fish Oil

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



7/08/2010

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Aust sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agree kept.,



All reports of adverse reactions or similar experiences associated with the use or administ of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponso of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,


Where a listed medicine is distributed overseas as well as in A outside Australia which has or may have relevance to the quali Manager Therapeutic Goods Administration, immediately the a

TGAeBS

be

Colouring agents used in listed medicine for ingestion, other a tion 25 of the Therapeutic Goods Act 1989, shall be only those included in the list of 'Colourings permi · http://www.tga.gov.au/industry/cm-colourings-oral-

29/06/2012

years of research. ild Fish Oil is free from high levels of environmenta.I toxins found in some sources of farmed fish.

elp to maintain general good health and are especially beneficial for the heart, brain, joints and eyes. important role in helping to maintain a healthy cardiovascular system, healthy blood pressure and support heart health.

sin healthy people and maintain healthy cholesterol levels. Omega-3 fat! provide an anti-inflammatory action and may help to reduce inflammation and joint swelling associated with arthritis. Contains DHA, needed for the maintenance of normal function of the eye, brain and nervous system DHA is the predominant fatty acid in the central nervous system which is found in the walls of brain cells contains 50% more omega-3s than regular 1000mg fish oil.

Pack Size Poison Schedule

Page 1 of2 Produced at 13.03.2014 at 02:31 :55 EST 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

)

Dosage Form



A.ctiv:e Ingredients.

Fish oil - natural

Capsule, soft

Oral

1.5 g

TGAeBS



Page 2 of2 Produced at 13.03.2014 at 02:31 :55 EST 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

)

TGAeBS

Public Summary

~~~!!!~!!:tgrc:~~f<~~ntw§i' o~: ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

174635 Swisse Ultiboost Cranberry

Medicine Listed



7/08/2010

Medicine

Revoked

Listed Medicines


The sponsor shall retain records of the distribution of the listed medicine for a period offive years ands to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request.,

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine~ in relation to the inclusion of the medicine in the Register., ·

All reports of adverse reactions or similar experiences associated with the use or ad min· of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponso of listed medicines must retain records of such reports for a period of not less than 18 months fro of the report or reports.,

The sponsor shall not supply the listed medicine after the expiry date of the,

Where a listed medicine is distributed overseas as well as in Aus outside Australia which has or may have relevance to the quality, Manager Therapeutic Goods Administration, immediately the a ·

lbe

Colouring agents used in listed medicine for ingestion, other th lion 25 of the Therapeutic Goods Act 1989, shall be only those included in the list of 'Colourings permit! · edi http://www.tga.gov.au/industry/cm-colourings-

Pack Size

Dosage Form


Page 1 of2

29/06/2012

cystitis. ants and possess unique anti-adhesion qualities that protect the urinary tract against the bacteria that causes

with cystitis symptoms and may help reduce the recurrence of cystitis s PACran®, a premium quality cranberry extract to support urinary tract health and help reduce the occurence of

en, standardised high potency cranberry extract and is a unique combination of the whole cranberry (not just the juice). h

Poison Schedule

Capsule, soft

Oral


)

)


. Active Ingredients



350 mg

17.5 g

TGAeBS


writt~p,,approval from the Commonwealth.Further details can be found at http://www.t?Cl·gov.au/about/website-copyright.htm.


)

Public Summary §11!!1'.'m~fy'ff:!r.N{t~ ~11~:·

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

174628 Swisse Ultiboost Cold Sore Combat

Medicine Listed



7/08/2010

Medicine

Revoked

Listed Medicines

TGAeBS

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an in 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 of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the good of listed medicines must retain records of such reports for a period of not less than 18 months from the of the report or reports.,


Where a listed medicine is distributed overseas as well as in Australia, product recall or an outside Australia which has or may have relevance to the quality, safety or efficacy of the Manager Therapeutic Goods Administration, immediately the action or information is known to

Colouring agents used in listed medicine for ingestion, other than those lisle be only those included in the list of 'Colourings permitted in medicines for ora http://www.tga.gov.au/industry/cm-colourings-oral-use.htm,as amended fro

The sponsor shall retain records of the distribution of the listed medi to the Office of Complementary Medicines, lherapeutic Goods

e the records or copies of the records

The sponsor shall keep records relating to this listed medici (b} Identify the manufacturer(s) of each batch of the listed medi

necessary of any batch of the listed medicine, ufacture in Australia of the listed medicine is

sub-contracted to a third party who is not the sponsor, · of r tice agreements relation to such manufacture shall be kept.

29/06/2012

r a long period. OR WARNING: Contains zinc which may be dangerous if taken in large

cold sores. Helps red the number/frequency of outbreaks of cold sores and reduces healing time of lesions. Relieves the severity of symptoms of cold sores such as itching, burning and pain. Vitamin C and zinc for the healing of lesions and healthy skin. Vitamin C is essential for collagen formation and helps maintain the integrity of connective tissue and skin. Cold sore relief Helps to support immune function in normal healthy individuals. Vitamin C has antioxidant properties, it helps to minimise the risk of cell damage attributed to free radicals. Supplementation of Vitamin C is recommended where dietary intake is inadequate and in particular in the elderly. Andrographis is an Ayurvedic herb that has been used traditionally to help maintain a healthy immune system As a supplement of Lysine.


)

Pack Size

1. Formulation 1

Dosage Form



.Activefnsret!i!!flts

Andrographis paniculata

Equivalent: Andrographis paniculata (Dry)

Ascorbic acid

Lysine hydrochloride


Poison Schedule

Tablet, film coated

Oral

21.05 mg

400 mg

250mg

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or com mer

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-cop

TGA eBS


)

Public Summary 1>.~61m~ t~r-~Rt<f.~t1try: . ·.

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

174619 Swisse Ultiboost Liquid Iron

Medicine Listed



7/08/2010

Medicine

Revoked

Listed Medicines


The sponsor shall retain records of the distribution of the listed medicine for a period offive years and sha to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request.,





TGAeBS

be

Colouring agents used in listed medicine for ingestion, other tion 25 of the Therapeutic Goods Act 1989, shall be only those included in the list of 'Colourings permit! · http://www.tga.gov.au/industry/cm-colourings-oral-

Product Type 29/06/2012

Drink plenty of water (or w

is inadequate. OR Vitamin supplements should not replace a balanced diet.,

l(s)] may have a laxative effect or cause diarrhoea [or words to that effect].,

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

Aids, assists or helps in the maintenance or improvement of general well-being and energy levels. All natural flavours, colours and sweeteners. Sweetened with xylitol, shown to be good for teeth health. No artificial additives. A source of iron for those with diets lacking in iron. A source of iron for those who may have higher requirements such as vegetarians, pregnant and breastfeeding women. Contains vitamin C which assists in the absorption of iron. contains B vitamins to help support energy levels. Contains herbs to help support general health and provide antioxidant support. Iron is an integral part of haemoglobin, an essential component of red blood cells, which transports oxygen around the body. Uses Sunative Iron, an encapsulated form of ferric pyrophosphate Studies have shown GIT symptoms such as constipation and the irritant and astringent action of iron are due to the "local action of iron". Gentle on the stomach. Sunactive iron is microencapsulated, this may help to reduce this local action and therefore GIT side effects. It also helps to increase absorption and


)

TGAeBS

bioavailability. Microencapsulation may help to slow release of iron molecules and therefore reduce the dose-related side effects such as constipation. Microencapsulation also helps to reduce any unpleasant taste when incorporated into a liquid formula. Based on 25 years of research. Provides supplementary iron support during pregnancy and breastfeeding and when the body requires increased levels of iron. Suitable for children.

Type

Bottle

Pack Size

Dosage Form

Material

Not recorded



Acti~e l~gr~CU11nl§.

Ascorbic acid

Cucurbita pepo

Equivalent: Cucurbita pepo (Dry)

Cyanocobalamin

Ferric pyrophosphate

Fucus vesiculosus

Equivalent: Fucus vesiculosus (Dry)

Hibiscus sabdariffa

Equivalent: Hibiscus sabdariffa (Dry)

Hippophae rhamnoides

Life Time

Not recorded

Equivalent: Hippophae rhamnoides (Juice fresh

Malpighia glabra

Equivalent: Malpighia glabra (Dry)

Prunus avium

Punica granatum

Equivalent: Punica gran

Withania somnifera

Equivalent: Withania somnifera (Dry)

Zingiber officinale

Equivalent: Zingiber officinale (Dry)

Temperature

Not recorded

Closure t< Conditions

Child resistant closure Not recorded

Poison Schedule

Oral Liquid, suspension

Oral

500 microgram/ml

200 microgram/ml

500 microgram/ml

100 microgram/ml

1.5 mg/ml

150 microgram/ml

600 microgram/ml

5 microgram/ml

500 microgram/ml

10 microgram/ml

500 microgram/ml

48.62 microgram/ml

137 microgram/ml

100 microgram/ml

600 microgram/ml

25 microgram/ml

1.75 mg/ml

500 microgram/ml

100 microgram/ml

400 microgram/ml

123 microgram/ml

100 microgram/ml

500 microgram/ml

100 microgram/ml

500 microgram/ml

25 microgram/ml

500 microgram/ml




~

& ~ li--l •

0 (/). ~ s s ~

~

)

)

TGAeBS

Public Summary :s•iUim~'XM Mi:~!?nw=,,

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

165267 Swisse Ultiboost Sleep

Medicine Listed



15/09/2009

Medicine

Revoked'-'

Listed Medicines


The sponsor shall retain records of the distribution of the listed medicine for a period of five years ands to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request.,


All reports of adverse reactions or similar experiences associated with the use or administf of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponso of listed medicines must retain records of such reports for a period of not less than 18 months fro of the report or reports.,

The sponsor shall not supply the listed medicine after the expiry date of the·

Where a listed medicine is distributed overseas as well as in Aust outside Australia which has or may have relevance to the quality, Manager Therapeutic.Goods Administration, immediately the a ·

be

Colouring agents used in listed medicine for ingestion, other t tion 25 of the Therapeutic Goods Act 1989, shall be only those included in the list of 'Colourings permit! · http://www.tga.gov.auflndustry/cm-colourings-o

29/06/2012

the assessment of clinical studies and contains scientifically validated ingredients shown to assist you to sleep like

mbination of herbs clinically proven to promote calmness and relaxation, The scientifically validated ingredients in Swisse lmness and relaxation, assist in relieving nervous tension and promote natural, restful sleep. combination of relaxing and sedative herbs - some used traditionally in Chinese medicine for several thousand years such as and licorice. These traditional herbs help to support the nervous system and the actions of main ingredients valerian and

hops. Valerian wn to help decrease sleep latency (the time taken to fall asleep) and assist with minimising sleep challenges. The anti-stress mineral, magnesium is also included as it works to relax both skeletal and smooth muscles - it is often used to help reduce muscle cramps. China root is also included for its assistance with nervous system disturbances such as insomnia. The natural ingredients included in Swisse Ultiboost Sleep are not addictive and will not disrupt REM sleep and cause morning grogginess the next day like some sleeping tablets may. REM sleep is the time during which you dream and is considered vital for mental health. Disturbance of REM sleep can lead to problems with concentration and memory as well as impaired learning.


Page 1 of2 Produced at 13.03.2014 at 02:18:23 EST 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

)

)

1. Formulation 1

Dosage Form



Kctive lngredieri!s

Anemarrhena asphodeloides

Equivalent: Anemarrhena asphodeloides (Dry)

Glycyrrhiza glabra

Equivalent: Glycyrrhiza glabra (Dry)

Humulus lupulus

Equivalent: Humulus lupulus (Dry)

Magnesium orotate

Poria cocos

Equivalent: Poria cocos (Dry)

Valeriana offlcinalis

Equivalent: Valeriana officinalis (Dry)

Tablet, film coated

Oral

-

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distr

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/a·


TGAeBS

10mg

50mg

12.Smg

50 mg

26.67 mg

200 mg



)

)

Public Summary ~!l'll~!iri.tW*tG,. i=~~!jr: ·.,.

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

164560 Swisse Ultiboost Wild Salmon Oil

Medicine Listed



24/08/2009

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia

TGAeBS

sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreeme ion t be kept.,

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and sha to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request.,

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine t in relation to the inclusion of the medicine in the Register.,

All reports of adverse reactions or similar experiences associated with the use or ad minis of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponso of listed medicines must retain records of such reports for a period of not less than 18 months fro of the report or reports.,


Where a listed medicine is distributed overseas as well as in Aus outside Australia which has or may have relevance to the quality, Manager Therapeutic Goods Administration, immediately th ·

Colouring agents used in listed medicine for ingestion, other be only those included in the list of 'Colo~rings permit! · http://www.tga.gov.au{Jndustry/cm-colourings-oral-u


29/06/2012

or) Temporary relief of osteoarthritic pain. [Warning S required],

S required],

Oil is based on 25 years of research and contains premium quality omega-3 fatty acids, DHA and EPA. It is one of the only sourced from wild Alaskan salmon that swim freely in the pristine waters of the Arctic Ocean - 'sustainable free range fish?.

mon Oil is free from high levels of environmental toxins found in some farmed fish. Swisse?s wild salmon oil is extracted using gravity and cess, similar to the extraction process of virgin olive oil. This process ensures that vitamin E in its natural form, d-alpha tocopherol, is used for its antioxidant properties. To assist in maintaining a healthy cardiovascular system, healthy skin and triglyceride levels. May reduce swelling associated with osteoarthritis and arthritis Omega-3 fatty acids may be beneficial for joint health. In particular EPA may help maintain cartilage health and collagen production. Natural vitamin E (d-alpha tocopherol) has strong antioxidant properties and unlike synthetic vitamin E, is easily recognised by the body to ensure high bioavailability. It has been shown that omega-3 fatty acids may play an important role in helping to maintain a healthy cardiovascular system by promoting circulation, healthy blood pressure and cholesterol levels in healthy individuals. DHA is the predominant fatty acid in the central nervous system which is found in the walls of brain cells and is important for the natural repair process. The body's highest concentrations of DHA are found in the photoreceptor cells of the retina, which help convert light into neural signals to make sense of what the eye is seeing. Swisse Ultiboost wild salmon oil will help to support the required daily levels of omega-3 that may be lacking due to insufficient intake from the diet. EPA is important for the maintenance and development of optimal brain function and cell signalling (the process of communication between nerve cells). Omega-3 fatty acids may help support bone health by influencing bone cell activity and reducing joint inflammation.


)

Pack Size

Dosage Form



!.t:_tive 1ngr~C1ien~

Fish oil - natural

Poison Schedule

Capsule, soft

Oral

1000 mg

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commer ·

·written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/we

TGAeBS


)

Public Summary §11mrtt~~"(9'r;~r~~Kntr¥: · · · 160963 Swisse Ultiboost Eye

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



8/04/2009

Medicine

Revoked

.Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Aust sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreeme kept., ·

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and sh to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request.,


All reports of adverse reactions or similar experiences associated with the use or adminis of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponso of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,



TGAeBS

be

Colouring agents used in listed medicine for ingestion, other a lion 25 of the Therapeutic Goods Act 1989, shall be only those included in the list of 'Colourings permi · http://www.tga.gov.au/industry/cm-colourings-oral-

10/12/2009 10:39:18 AM

r a long period. OR WARNING: Contains zinc which may be dangerous if taken in large

e is inadequate. OR Vitamin supplements should not replace a balanced diet.

Swisse Ult s based on 25 years of research and contains scientifically validated ingredients to assist in providing relieffrom visual fatigue and eye strain. Swisse Ultiboost EYE is based on the assessment of clinical studies that show certain ingredients in the formula can assist in promoting healthy vision. Swisse Ultiboost EYE is recommended for people who experience problems with night vision and those sensitive to glare. Used as directed, Swisse Ultiboost EYE may deliver positive results relatively quickly. If you suffer from any medical conditions, please consult your health care professional for advice on the suitability of this product for you. Use only as directed and see your health care professional if symptoms persist


1. Formulation 1


)

Dosage Form



Active !11gr~dierits

Calcium ascorbate

Cupric sulfate pentahydrate

d-alpha-Tocopheryl acid succinate

Tagetes erecta

Equivalent: Tagetes erecta (Dry)

Tocopherols concentrate - mixed (low-alpha type)

Zinc oxide

Tablet, film coated

Oral

250 mg

3.93mg

165.2928 mg

60mg

330 mg

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commer ·

written approval from the Commonwealth.Further details can be found at http:/lwww.tga.gov.au/abouVwe

TGAeBS


_)

)

Public Summary ~ilmm~l"Ymr~~~r~!SilJW:::::/·· · 164154 Swisse Ultiboost Odourless Fish Oil

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



6/08/2009

Medicine

Revoked

Listed Medicines

.~f.




All reports of adverse reactions or similar experiences associated with the use or adminis of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponso of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,

The sponsor shall not supply the listed medicine after the expiry date of the,


TGAeBS

be

Colouring agents used in listed medicine for ingestion, othe be only those included in the list of 'Colourings permi http://www.tga.gov.au/industry/cm-colourings-oral-u


29/06/2012

diovascular system, health skin and triglyceride levels. OF RESEARCH

re based on the assessment of clinical studies and incorporate highest grade, scientifically validated ingredients which have Its.

Benefits: S ost Odourless Fish Oil is based on 25 years of research and contains premium quality omega-3 fatty acids, DHA and EPA. It is one of the only fish oils that is sourced from wild fish that swim freely in the pristine waters of the Pacific Ocean ? our version of "sustainable free range fish?. Swisse Ultiboost Odourless Fish Oil is free from high levels of environmental toxins found in some sources of farmed fish. Studies show that fish oils help to maintain general good health and are especially beneficial for the heart, brain, joints and eyes. It has been shown that Omega-3 fatty acids may play an important role in helping to maintain a healthy cardiovascular system by promoting circulation and healthy blood pressure and cholesterol levels. Omega-3 fatty acids may also help support bone health by influencing bone cell activity and reducing joint inflammation. DHA is the predominant fatty acid in the central nervous system which is found in the walls of brain cells and is important for the natural repair process. Omega-3 fatty acids may be beneficial for joint health. In particular EPA may help maintain cartilage health and collagen production. Does not contain artificial chemicals such as polysorbate to reduce the reflux action and fishy after taste. Swisse Vitamins have launched an advanced new odourless fish oil supplement that delivers premium quality omega-3 fatty acids, DHA and EPA. Swisse Ultiboost Odourless Fish Oil capsules contain natural spearmint oil and vanilla flavour to ensure no 'fishy? after taste. Omega-3 fatty acids are vital for vision and play a structural and functional role in the retinal and nerve cells of the eye. The body?s highest concentrations of DHA are found in the photoreceptor cells of the retina, which help convert light into neural signals to make sense of what the eye is seeing.


)

TGAeBS

- The fattty acids from the fish oil are important structural components of the phospholipids membranes of cells thoughout the body

Type

Jar/Can

Pack Size

Dosage Form

Material

Not recorded



Mt~yeli!9r&,liE!l1ts

Fish oil - natural

Life Time

Not recorded

Temperature

Not recorded

Poison Schedule

Capsule, soft

Oral

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, dis

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/ab


Closure

Not recorded

Conditions

Not recorded



)

)

TGAeBS

Public Summary '~ufui"i!#Ji>,r;~r~~~b.ti'Y1>·· 160943 Swisse Ultiboost Executive Focus

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



8/04/2009

Medicine

Rivoked

Listed Medicines




All reports of adverse reactions or similar experiences associated with the use or adminis of Product Review, Therapeutic Goods Administration, as soon as practicable after the spons of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,



lbe

ds

The Ginkgo biloba leaf extract used in the manufacture of this Powdered Ginkgo Extract in the United States Pharm · 32 -


dried leaf.,

Colouring agents used in listed medicine for ing be only those included in the list of 'Colourings http://www.tga.gov.au/industry/cm-colou

ly under section 25 of the Therapeutic Goods Act 1989, shall bleat

time.

Effective date 23/06/2010 10:13:13 AM

CUS is based on 25 years of research and contains scientifically validated ingredients to assist in memory function and TIVE FOCUS is based on the assessment of clinical studies that show certain ingredients in the formula can improve

e mental alertness, help to relieve anxiety and stress. Swisse Ultiboost EXECUTIVE FOCUS helps to improve brain functions !ration. Used as directed, Swisse Ultiboost EXECUTIVE FOCUS may deliver positive results relatively quickly.

If you s al conditions, please consult your health care professional for advice on the suitability of this product for you. Use only as directed and see your health care professional if symptoms persist. Vitamin supplements should not replace a balanced diet.

Type

Bottle

Page 1 of2

Material

Not recorded

Life Time

Not recorded


Temperature

Not recorded

Poison Schedule

Closure

Not recorded

Conditions

Not recorded


The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visitwww.tga.gov.au for contact information

)

,;~i>riJJigil~:~t~;' ~ ' .c

1. Formulation 1

Dosage Form



Bacopa monnieri

,, .. , Calcium pantothenate

Cyanocobalamin

Ginkgo biloba

Equivalent: Ginkgo biloba (Dry)

Nicotinamide


Riboflavin

Thiamine

Tablet, film coated

Oral

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distri written approval from the Commonwealth.Further details can be found at http://www.tga.gov.


3.5 g

70 microgram

25 microgram

60mg

3g

TGAeBS



)

)

Public Summary .§4~!1J~!Y,tM;&;~fG, i:ntF¥= : ;. .. 150942 Swisse Ultiboost Heart

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



8/04/2009

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Aust sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreement kept., ·

The sponsor shall retain records of the distribution cif the listed medicine for a period of five years and s to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request.,


All reports of adverse reactions or similar experiences associated with the use or ad minis of Product Review, Therapeutic Goods Administration, as soon as practicable after the spons of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,


TGAeBS

be

Where a listed medicine is distributed overseas as well as in Aus -Outside Australia which has or may have relevance to the quality, Manager Therapeutic Goods Administration, immediately the ·

taken in relation to the medicine

Colouring agents used in listed medicine for ingestion, other be only those included in the list of 'Colourings permit! · http://www.tga.gov.au/industry/cm-colourings-oral-

Where the medicine is a conventional release i the additional conditions are as follows: Where this medicine must comply with the diss Tablets. Where the medicine con dissolution requirements in the U Supplement. The dissolution c shelf life of the product when the analytical methods fort apply to chewable, effe

in Australia, must be notified to the National

tion 25 of the Therapeutic Goods Act 1989, shall

m, of strength of 100 micrograms or more per dosage unit, gle active ingredient, the dissolution characteristics for folic acid in

rmacopoeia 24th Edition (USP24) monograph for Folic Acid aracteristics for folic acid in this medicine must comply with the

P24) monograph for Nutritional Supplements, as amended by its First h the dissolution requirements of the relevant USP24 monograph over the uct label. It is the responsibility of manufacturers to develop and validate

in conjunction with the USP24 dissolution criteria. This condition does not ined release tablets.


xic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not

Protects capillaries.,

Maintain health of capillaries.,


May assist blood circulation.

- Support for Healthy Heart & Cholesterol - Swisse Ultiboost HEART has been developed by a professor and contains scientifically validated ingredients that help maintain a healthy cardiovascular system. Ultiboost HEART assists in the maintenance of healthy heart tissue and function as well as protecting capillaries and helping maintain normal blood circulation. Ultiboost HEART also assists in the maintenance of healthy cholesterol level, which is so important for the overall wellbeing of the cardiovascular system.Ultiboost HEART may deliver positive results relatively quickly.For better results: Ultiboost HEART may be effective when used on it's own, however we recommend you· use this product in conjunction with Swisse Women's or Men's


)

)

TGAeBS

Ultivite which act as a "foundation" to provide the body with the important nutrients necessary for general well being. Has antioxidant action via its free radical scavenging properties.

Dosage Form



Active lrigr~ients

Calcium ascorbate

Cholecalciferol

Cyanocobalamin

Folic acid


Selenomethionine

Ubidecarenone

©Commonwealth of Australia.This work is copyright.You are not permitted to

written approval from the Commonwealth.Further details can be found at http://


Poison Schedule

Tablet, film coated

Oral



Public Summary §~fiim~t¥tRrl~T~~r•ni:··• .. ; 164144 Swisse Ultiboost Vitamin C

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



6/08/2009

Medicine

Revoked

Listed Medicines



The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine f in relation to the inclusion of the medicine in the Register.,

All reports of adverse reactions or similar experiences associated with the use or administ of Product Review, Therapeutic Goods Administration, as soon as practicable after the spans of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,

The sponsor shall not supply the listed medicine after the expiry date of th

Where a listed medicine is distributed overseas as well as in Aust outside Australia which has or may have relevance to the quality, Manager Therapeutic Goods Administration, immediately the

TGAeBS

be·

Colouring agents used in listed medicine for ingestion, other ction 25 of the Therapeutic Goods Act 1989, shall be only those included in the list of 'Colourings permit! · http://www.tga.gov.au/industry/cm-colourings-oral-u

28/08/2009 9:44:39 AM

age without medical advice (or words to that effect).,

d on the assessment of clinical studies and incorporate highest grade, scientifically validated ingredients which have s. amin C is based on 25 years of research and contains scientifically validated ingredients to help reduce the severity and

art the body?s normal resistance to colds and flu. Vitamin C is a potent antioxidant which can help reduce the risk of cell damage Is. Vitamin C also helps to enhance the absorption of dietary iron and may help promote skin health and wound healing because of its involvement in the manufacture of collagen. Swisse Ultiboost Vitamin C is derived from non acidic calcium ascorbate making it gentle on the stomach. -antioxidant, helps to reduce free radical damage -may help to boost your immune system -traditionally, vitamin c may help to reduce histamine levels, helping in the management of some allergies - vitamin c may help improve normal, healthy immune function - vitamin c is water soluble and is not stored in the body, therefore regular/daily intake is desirable

Type Material Life Time Temperature Closure Conditions

Page 1 of2 Produced at 13.03.2014 at 02:17:14 EST This is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of the infonnation on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

)

Jar/Can Not recorded

Dosage Form


, , Visual Identification

Ac;tiv11 tllgr!ldleiits ·


Ubidecarenone

Not recorded Not recorded

Poison Schedule

Tablet, film coated

Oral

Not recorded

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or comm

written approval from the Commonwealth.Further details can be found at http:f/www.tga.gov.au/abouVwebsi

TGAeBS

Not recorded


)

Public Summary

.~ilrl!m11tY:t1r,,Mt~~NN=- · ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

163780 Swisse Ultiboost Fish Oil

Medicine Listed



27/07/2009

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b} Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia

TGAeBS

sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreemen ion t kept.,



All reports of adverse reactions or similar experiences associated with the use or adminisf of Product Review, Therapeutic Goods Administration, as soon as practicable after the spans of listed medicines must retain records of such reports for a period of not less than 18 months fro of the report or reports.,

The sponsor shall not supply the listed medicine after the expiry date of the·

n taken in relation to the medicine

be


in Australia, must be notified to the National

Colouring agents used in listed medicine for ingestion, other be only those included in the list of 'Colourings permi · http://www.tga.gov.auflndustry/cm-colourings-oral-


10/12/200910:39:18 AM


rds to that effect).

Swisse Ulti OIL is extracted using a low heat process, similar to the extraction process of virgin COLD-PRESSED olive oil, to decrease degradation that can occur during heated extraction methods. To assist in maintaining a healthy cardiovascular system, healthy skin and triglyceride levels. May reduce swelling associated with osteoarthritis and arthritis

May help to maintain healthy triglyceride levels Many help to maintain health blood pressure May help to maintain cardiovascular health


Poison Schedule



)

(:~TB<>ni~~~ :' 1. Formulation 1

Dosage Form



Active ln9redients

Alpha tocopherol

fish oil - natural

Capsule, soft

Oral

33.56 mg

1000 mg

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise them~

written approval from the Commonwealth .Further details can be found at http://www.tga.gov .au/about/website-copyright.ht ' .

TGAeBS


)

Public Summary ~uwm~ fl>t'~t§ gt1tQi':

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

160944 Swisse Ultiboost Hair Skin Nails

Medicine Listed



8/04/2009

Medicine

Revoked

Listed Medicines




All reports of adverse reactions or similar experiences associated with the use or administ of Product Review, Therapeutic Goods Administration, as soon as practicable after the spans of listed medicines must retain records of such reports for a period of not less than 18 months fro of the report or reports.,


Where a listed medicine is distributed overseas as well as in Austra outside Australia which has· or may have relevance to the qualit Manager Therapeutic Goods Administration, immediately the a

TGAeBS

be

Colouring agents used in listed medicine for ingestion, other be only those included in the list of 'Colourings permit! ·


http://www.tga.gov.au/industry/cm-colouring

Product Type

Vitamins can only be of

29/06/2012

ke is inadequate. OR Vitamin supplements should not replace a balanced diet.,

to that effect).,

a formula containing scientifically validated ingredients, based on clinical studies, which nourish and protect from the ients to support the building blocks of hair, skin and nails, as well as maintaining their health and appearance. This

e brittle and thinning hair and weak, splitting nails. Nails works by delivering nourishment via the bloodstream to the skin, hair follicles and nail beds. This is an internal systemic to support the topical applications such as moisturising creams or conditioners.

Swisse Ultib Nails is a comprehensive formula containing biotin which is essential to help strengthen soft, brittle nails and reduce breaking and splitting. Clinical studies have shown biotin to increase nail thickness by up to 25 percent when taken over a 12 week period at the dosage included in Swisse Ultiboost Hair Skin Nails. · Silica is also included for the fomnation of collagen. Collagen provides a structural framework for the skin by supporting its thickness and integrity. Zinc also assists with collagen production and is particularly important for wound healing. It has also been shown to assist in minimising skin blemishes. St. Mary's Thistle is a unique inclusion in Swisse Ultiboost Hair Skin Nails. This potent antioxidant has been used traditionally for thousands of years as a 'Spring Tonic' and detoxifier and current clinical studies support its use in liver conditions and for liver cell regeneration. It can help improve skin appearance and reduce blemishes via its detoxification action on the liver. By providing the body with the key nutrients in Swisse Ultiboost Hair Skin Nails which have a proven role in maintaining the health of skin, hair and nails ? the body will be nourished from the inside which will in turn be reflected on the outside.


)

Pack Size

Dosage Form



Act!llti lngreqi~nts

Biotin ,,\

Calcium ascorbate

Ferrous fumarate

Silica - colloidal anhydrous

Silybum marianum

Zinc gluconate

Poison Schedule

Tablet, film coated

Oral

2.6mg

60.52 mg

16.01 mg


written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/abouVwebsite-cop

TGAeBS


)

TGAeBS

Public Summary ~~rnm~WtkrM,f~,~!!¥Y.~ . · 157270 Swisse Women's Ultivite Multi-Vitamin, Mineral and Anti-Oxidant with Herbs Formula 2

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



2/12/2009

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Aust sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreemen kept., ·


The sponsor of the listed medicine must not, by any means, intentionally or recklessly adv~rtise the medicine~ in relation to the inclusion of the medicine in the Register.,

All reports of adverse reactions or similar experiences associated with the use or adminis of Product Review, Therapeutic Goods Administration, as soon as practicable after the spans of listed medicines must retain records of such reports for a period of not Jess than 18 months fr of the report or reports.,



Jbe

The Ginkgo biloba leaf extract used in the manufacture of this Powdered Ginkgo Extract in the United States Phar 32 -


dried leaf.,

Colouring agents used in listed medicine for i be only those included in the list of 'Colourings p http://www.tga.gov.au/industry/cm-colouri s-oral-

Where the medicine is a conventionaf the additional conditions are as foll this medicine must comply Tablets. Where the medici

under section 25 of the Therapeutic Goods Act 1989, shall able at

on, in tablet form, of strength of 100 micrograms or more per dosage unit, · as a single active ingredient, the dissolution characteristics for folic acid in

States Pharmacopoeia 24th Edition (USP24) monograph for Folic Acid Jution characteristics for folic acid in this medicine must comply with the

4th Edition (USP24) monograph for Nutritional Supplements, as amended by its First ust comply with the dissolution requirements of the relevant USP24 monograph over the ed on the product label. It is the responsibility of manufacturers to develop and validate ould be used in conjunction with the USP24 dissolution criteria. This condition does not

ined release tablets.

ium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not

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

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

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

(If medicine contains one sugar) contains [insert name of sugar] OR (If medicine contains two or more sugars) Contains sugars [or words to that effect].,

Contains lactose (or words to that effect}.,

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

For mineral (may state the mineral} supplementation.,

Prevention/treatment of vitamin [XX] and/or mineral [YYJ and/or nutritional deficiencies (This indication is not be to used for the treatment of iron deficiency conditions).,


)

)



For vitamin (may state the vitamin) supplementation.

Assists in supporting a healthy cardiovascular system contains antioxidants to assist in decreasing the risk of cell damage from free radicals. Assists in maintaining a healthy and normal immune system.

1. Formulation

Dosage Form



A~iive.·1rigredi~t1tS

Bifidobacterium longum

Biotin


Calcium orotate


Cholecalciferol

Choline bitartrate

Chromium picolinate

Cinnamomum cassia

Equivalent: Cinnamomum cassia (Dry)


Copper gluconate

Crataegus monogyna

Equivalent: Crataegus monogyna (Dry

Cyanocobalamin

Cynara scolymus

Folic acid

Phytomenadione

Potassium iodide


Retinyl acetate

Riboflavin

Selenomethionine

Silybum marianum


Spearmint Oil

Thiamine hydrochloride


Poison Schedule

Tablet, film coated

Oral

TGAeBS

402 microgram

6.67mg

100 mg

20mg

14.29mg

12.5mg

SO mg

120 microgram

12.5mg

SO mg

20mg

500 microgram

20mg

1 g

6.25mg

15mg

Omg

Omg

110 mg

40mg

67.5 microgram

50mg

60 microgram

52.32 microgram

30mg

142.5712 microgram

30mg

65 microgram

14.29mg

1 g

2mg

55mg



)

)

Trigonella foenum-graecum

Equivalent: Trigonella foenum-graecum (Dry)

Ubidecarenone

Urtica dioica




Vaccinium myrtillus

Vitis vinifera


Withania somnifera

Equivalent: Withania somnifera (Dry)




150 mg

18.759

1.0005 mg

20mg

100 mg

20mg

1000 mg

2mg

8.33mg

1 g

20mg

200 mg

TGAeBS


Public Summary Mmm~ii¥f!>r~f~·i;,11:~IrL · 168780 Swisse Ultiboost Calcium + D

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



4/02/2010

Medicine

Revoked

Listed Medicines


The sponsor shall retain records of the distribution of the listed medicine for a period offive years and sh to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request.,


All reports of adverse reactions or similar experiences associated with the use or adminis of Product Review, Therapeutic Goods Administration, as soon as practicable after the spons of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,


Where a listed medicine is distributed overseas as well as in Aust outside Australia which has or may have relevance to the quality, Manager Therapeutic Goods Administration, immediately th ·

TGAeBS

be

Colouring agents used in listed medicine for ingestion, other be only those included in the list of 'Colourings permi http://www.tga.gov.au/industry/cm-colourings-oral-


3/03/2010 11 :14:01 AM

ke is inadequate. OR Vitamin supplements should not replace a balanced diet.,

ords to that effect).

increased after menopause.,

to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium issue for children and older adults.,

n our youth and throughout life is required to maximise bone.,

Vitamin 03 and calcium supplement for when these vitamins/minerals are lacking in the diet Vitamin D supplementation may assist in regulation of calcium metbolism and bone mineralization in those not obtaining sufficient vitamin D due to diet or lifestyle factors Vitamin D promotes the body?s absorption of calcium, important to maintain healthy bones and teeth A supplement to aid in the management of calcium deficiency states Helps maintain healthy bones and teeth Calcium requirements may be increased with age, gender, diet, pregnancy and !action ? provides supplemental calcium Women?s calcium needs are increased after menopause Formulated using the citrate form of calcium, shown to have a higher bioavailability than other forms of calcium Patented black pepper extract (piper nigrum) Bioperine contains active ingredient piperine, shown to help increase nutrient uptake


)

Pack Size

1. Formulation 1

Dosage Form



A,ctL~e .. lnsredients

Calcium citrate

Cholecalciferol

Piper nigrum

Equivalent: Piper nigrum (Dry)

Poison Schedule

Tablet, film coated

Oral

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or comllJ

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/webslte-

1.5797 g

.0083 mg

TGAeBS


)

Public Summary $limro~iYJ~rA~f<3. ~ntw';: · ~ 157728 Swisse Ultiboost Pregnancy Fish Oil

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



10/12/2008

Medicine

Revoked

Listed Medicines



The sponsor of the listed medicine must not, by any means, intentionally.or recklessly advertise the medicine~ in relation to the inclusion of the medicine in the Register.,



Where a listed medicine is distributed overseas as well as in Aust outside Australia which has or may have relevance fo the quality, Manager Therapeutic Goods Administration, immediately t

TGAeBS

be

Colouring agents used in listed medicine for ingestion, other !ha be only those included in the list of 'Colourings permi edi


http://www.tga.gov.au/industry/cm-colourings-oral-

Dosage Form



A~tive lngn~aie11ts


31/05/2011 12:08:48 PM


rds to that effect).

aintaining healthy skin. Helps to assist in the maintenance of normal eye and brain function. It is function of the brain and nervous system. Assists in promoting the health of mother and baby. May ngs.

Temperature

Not recorded

Poison Schedule

Capsule, soft

Oral

Closure

Not recorded

Conditions

Not recorded



d-alpha-Tocopherol

Fish oil - natural

33.56mg

1000 mg

TGAeBS



Page2of2 Produced at 13.03.2014 at 02:13:13 EST 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

)

)

TGAeBS

Public Summary i>~it\~#1)'.t~~Mf~J;~tiY; · 167269 Swisse Men's Ultivite Multi-Vitamin Mineral & Anti-Oxidant with Herbs Formula 2

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed


36-38 Gipps Street, COLLINGWOOD, VIC, 3066 Australia·

2/12/2009

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Austra sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreemen ion to kept., ·



All reports of adverse reactions or similar experiences associated with the use or adminisr of Product Review, Therapeutic Goods Administration, as soon as practicable after the spons of listed medicines must retain records of such reports for a period of not less than 18 months fro of the report or reports.,



The Ginkgo biloba leaf extract used in the manufacture of this Powdered Ginkgo Extract in the United States Pha · 32 -dried leaf.,

be

Colouring agents used in listed medicine for ing be only those included in the list of 'Colourings

nly under section 25 of the Therapeutic Goods Act 1989, shall leat

http://www.tga.gov.au/industry/cm-colouri ral-

Where the medicine is a conventiona. the additional conditions are as follo this medicine must comply Tablets. Where the medici

on, in tablet form, of strength of 100 micrograms or more per dosage unit, id as a single active ingredient, the dissolution characteristics for folic acid in

States Pharmacopoeia 24th Edition (USP24) monograph for Folic Acid issolution characteristics for folic acid in this medicine must comply with the

24th Edition (USP24) monograph for Nutritional Supplements, as amended by its First ust comply with the dissolution requirements of the relevant USP24 monograph over the

ded on the product label. It is the responsibility of manufacturers to develop and validate ould be used in conjunction with the USP24 dissolution criteria. This condition does not

lets or sustained release tablets.

ance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.,

in excess of 3000 micrograms retinol equivalents, vitamin A can cause birth defects.,

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

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

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 take while on warfarin therapy without medical advice.

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).,

For mineral (may state the mineral) supplementation.,

For vitamin (may state the vitamin) supplementation.,




)


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

May assist in supporting a healthy cardiovascular system Provides support for the nervous system and is beneficial during times of stress. Contains antioxidants to assist in decreasing the risk of cell damage from free radicals.

Dosage Form



Ac::tiv~ !ri_gr~clien;ts

Bifidobacterium longum

Biotin


Calcium orotate


Cholecalciferol

Choline bitartrate

Chromium picolinate

Cinnamomum cassia

Equivalent: Cinnamomum cassia (Dry)


Copper gluconate

Crataegus monogyna

Equivalent: Crataegus monogyna (Dry)

Cyanocobalamin

Cynara scolymus

Inositol

Potassium iodide


Retinyl acetate

Riboflavin

Selenomethionine

Serenoa repens


Silybum marianum


Spearmint Oil


"'' Poison Schedule

Tablet, uncoated

Oral

100 mg

100 mg

21.43 mg

25mg

100 mg

TGAeBS

120 microgram

12.5mg

50 mg

25mg

500 microgram

20mg

1000 mg

6.25 mg

20 mg

Omg

Omg

110 mg

50 mg

67.5 microgram

55mg

70 microgram

52.32 microgram

20mg

.1487 mg

35mg

65 microgram

10 mg

100 mg

17.14 mg

1.2 g

2mg



)

Thiamine hydrochloride

Trigonella foenum-graecum

Equivalent: Trigonella foenum-graecum (Dry)

Ubidecarenone

Urtica dioica



Equivalent: Vaccinium macrocarpon (Juice fresh)

Vaccinium myrtillus

Vitis vinifera



. ,,


written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/abouVwebsit ·

60mg

150 mg

18.75 g

.3mg

20mg

100 mg

20mg

1000 mg

200 mg

8.33 mg

1 g

100 mg

TGAeBS


.)

)

TGAeBS

Public Summary

,~,~mmf!o/t~rc~t~I~iJ~i¥t'" · ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

166876 Swisse Ultiboost Eye

Medicine Listed



17/11/2009

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Aust sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreement kept.,



All reports of adverse reactions or similar experiences associated with the use or ad minis! of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponso of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,

The sponsor shall not supply the listed medicine after the expiry date of the··

Where a listed medicine is distributed overseas as well as in A outside Australia which has or may have relevance to the quali Manager Therapeutic Goods Administration, immediately the a

I be

Colouring agents used in listed medicine for ingestion, othe tion 25 of the Therapeutic Goods Act 1989, shall be only those included in the list of 'Colourings permit! · http://www.tga.gov.auflndustry/cm-colourings-oral-

31/05/2011 12:08:48 PM

e is inadequate. OR Vitamin supplements should not replace a balanced diet.,

words to that effect).

help maintain healthy eyes and vision. tes erecta, from Xangold, a patented extract of the marigold flower) - a rich source of lutein and zeaxanthin.

and zeaxanthin are found naturally in the eye, particularly the macular area of the retina. They help protect the eye from d therefore may help support eye health. health of macular region of the eye.

Contains zinc, t for healthy vision. The retina contains one of the highest concentrations of this mineral. Natural vitamin E and vitamin C further help to reduce free radical damage. Vitamin C is the first line of antioxidant protection in the body and is also responsible for regenerating oxidised vitamin E , enhancing the antioxidant effect of the natural vitamin E.Natural vitamin E is recognised best by the body and therefore has greater benefits than synthetic forms. Swisse Ultiboost EYE is based on 25 years of research and contains scientifically validated ingredients to assist with eye health. Swisse Ultiboost EYE is based on the assessment of clinical studies that show certain ingredients in the formula can assist in promoting healthy vision.



)

1. Formulation 1

Dosage Form



Active lngredilmts

Calcium ascorbate

Cupric sulfate pentahydrate

d-alpha-Tocopheryl acid succinate

Tagetes erecta

Equivalent: Tagetes erecta (Dry)

Tocopherols concentrate - mixed (low-alpha type)

Zinc oxide

Tablet, film coated

Oral


written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/we

250 mg

3.93mg

1~5.2928 mg

60mg

330 mg

TGAeBS


FOI 127-1314 document 24 part 5

Documents

Transcript of FOI 127-1314 document 24 part 5