BLACKMORES WOMEN'S CONCEPTION CARE PLATINUM

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

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Active ingredient:
ascorbic acid,betacarotene,Biotin,calcium ascorbate dihydrate,calcium citrate,calcium pantothenate,choline bitartrate,colecalciferol,cupric sulfate,cyanocobalamin,d-alpha-tocopheryl acetate,docosahexaenoic acid (DHA)-rich oil derived from microalgae Schizochytrium sp.,folic acid,heavy magnesium oxide,iron (II) glycinate,manganese sulfate monohydrate,nicotinamide,potassium iodide,pyridoxal 5-phosphate monohydrate,riboflavine,selenomethionine,thiamine hydrochloride,ubidecarenone,zinc amino acid
Available from:
Blackmores Ltd
Authorization status:
Listed
Authorization number:
346333

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Public Summary

Summary for ARTG Entry:

346333

BLACKMORES WOMEN'S CONCEPTION CARE PLATINUM

ARTG entry for

Medicine Listed

Sponsor

Blackmores Ltd

Postal Address

PO Box 1725, WARRIEWOOD, NSW, 2102

Australia

ARTG Start Date

21/10/2020

Product Category

Medicine

Status

Active

Approval Area

Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in the list

of 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b)

Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is sub-contracted

to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records to the

Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine outside

Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National Manager

Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1 . BLACKMORES WOMEN'S CONCEPTION CARE PLATINUM

Product Type

Composite Pack

Effective Date

21/10/2020

Permitted Indications

Antioxidant/Reduce free radicals formed in the body

Maintain/support general health and wellbeing

Maintain/support female reproductive system health

Helps maintains/support healthy foetal CNS/brain development

Maintains/support healthy foetal development

Maintain/support maternal health when dietary intake is inadequate

Help to prevent neural tube defects such as spina bifida and/or anencephaly

Maintain/support preconception health

Helps prepare the body for pregnancy

Indication Requirements

Indication can only be used for medicines that contain folic acid as an active ingredient and the recommended daily dose of the medicine provides a

minimum of 400 micrograms of folic acid. Product presentation referring to the prevention of neural tube defects must include at least one of the following

label statements: when trying to conceive and during the first trimester of pregnancy, and/or when taken at least four weeks before conception and during

the first trimester of pregnancy.

If directed to women, Label statement: Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester.

Product presentation must not imply or refer to infertility.

Label statement: If you are concerned about the health of yourself or your baby, talk to your health practitioner.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Do not take while on warfarin therapy without medical advice.

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

exceeded.

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

Public Summary

Page 1 of

Produced at 12.01.2021 at 12:28:49 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

words to that effect).

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 2

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

ascorbic acid

50 mg

Biotin

30 microgram

calcium ascorbate dihydrate

60.5 mg

Equivalent: ascorbic acid

50 mg

calcium citrate

474 mg

Equivalent: calcium

100 mg

calcium pantothenate

5.45 mg

Equivalent: pantothenic acid

5 mg

choline bitartrate

278.3 mg

Equivalent: choline

110 mg

cupric sulfate

3.28 mg

Equivalent: copper

1.3 mg

cyanocobalamin

.0026 mg

folic acid

500 microgram

heavy magnesium oxide

175 mg

Equivalent: magnesium

100 mg

iron (II) glycinate

66.6 mg

Equivalent: iron

18 mg

manganese sulfate monohydrate

15.4 mg

Equivalent: manganese

5 mg

nicotinamide

18 mg

potassium iodide

197 microgram

Equivalent: iodine

150 microgram

pyridoxal 5-phosphate monohydrate

2.98 mg

Equivalent: pyridoxine

1.9 mg

riboflavine

1.5 mg

selenomethionine

163 microgram

Equivalent: selenium

65 microgram

thiamine hydrochloride

1.68 mg

Equivalent: thiamine

1.5 mg

zinc amino acid chelate

75 mg

Equivalent: zinc

15 mg

Other Ingredients (Excipients)

Carnauba Wax

chlorophyllin-copper complex

citric acid

colloidal anhydrous silica

croscarmellose sodium

Public Summary

Page 2 of

Produced at 12.01.2021 at 12:28:49 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

hypromellose

macrogol 400

macrogol 8000

magnesium stearate

maltodextrin

mannitol

microcrystalline cellulose

purified talc

tartaric acid

titanium dioxide

2 . Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

betacarotene

1.5 mg

colecalciferol

.025 mg

d-alpha-tocopheryl acetate

15 mg

Equivalent: d-alpha-tocopheryl acetate

20.4 IU

docosahexaenoic acid (DHA)-rich oil derived from microalgae Schizochytrium sp.

469.725 mg

ubidecarenone

60 mg

Other Ingredients (Excipients)

ascorbyl palmitate

chlorophyllin-copper complex

colloidal anhydrous silica

dl-alpha-tocopherol

Gelatin

glycerol

hydrogenated vegetable oil

iron oxide yellow

lecithin

medium chain triglycerides

mixed (low-alpha type) tocopherols concentrate

purified water

Rosmarinus officinalis

Soya Oil

Sunflower Oil

vegetable oil

yellow beeswax

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

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

Public Summary

Page 3 of

Produced at 12.01.2021 at 12:28:49 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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