BLACKMORES MULTIVITAMIN FOR 50+

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

Buy It Now

Active ingredient:
ascorbic acid,borax,Biotin,calcium hydrogen phosphate,calcium pantothenate,chromic chloride hexahydrate,colecalciferol,colloidal anhydrous silica,cyanocobalamin,d-alpha-tocopherol,ferrous fumarate,folic acid,heavy magnesium oxide,manganese sulfate monohydrate,nicotinamide,potassium iodide,pyridoxine hydrochloride,retinol palmitate,riboflavine,selenomethionine,thiamine nitrate,Tagetes erecta,ubidecarenone,zinc sulfate monohydrate
Available from:
Blackmores Ltd
Authorization status:
Listed
Authorization number:
322617

Public Summary

Summary for ARTG Entry:

322617

BLACKMORES MULTIVITAMIN FOR 50+

ARTG entry for

Medicine Listed

Sponsor

Blackmores Ltd

Postal Address

PO Box 1725,WARRIEWOOD, NSW, 2102

Australia

ARTG Start Date

3/09/2019

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

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

the list of 'Colourings permitted in medicines for oral use'.

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

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

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

kept.

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

to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted

in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office

of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors

of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified

of the report or reports.

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

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

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

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

Products

1. BLACKMORES MULTIVITAMIN FOR 50+

Product Type

Single Medicine Product

Effective date

3/09/2019

Permitted Indications

Antioxidant/Reduce free radicals formed in the body

Helps reduce/decrease free radical damage to body cells

Maintain/support collagen formation

Maintain/support collagen health

Maintain/support energy production

Maintain/support eye health

Maintain/support healthy eyesight/vision

Maintain/support general health and wellbeing

Maintain/support connective tissue health

Maintain/support bone health

Maintain/support immune system health

Maintain/support healthy immune system function

Maintain/support (state vitamin/mineral) within normal range

Maintain/support cognitive function/mental function when dietary intake is inadequate

Maintain/support brain health when dietary intake is inadequate

Maintain/support nervous system health

Maintain/support nervous system function

Maintain/support skin health

Maintain/support skin integrity/structure

Indication Requirements

Public Summary

Page 1 of

Produced at 29.09.2019 at 05:28:46 AEST

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

Product presentation must not imply or refer to vision correction, faults or serious eye disease e.g. macular degeneration.

Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not

replace a balanced diet.

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis,

osteoporosis.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

Product presentation must not imply or refer to serious immunological diseases.

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased

physical activity.

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

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.

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

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

for men.

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.

Do not take while on warfarin therapy without medical advice.

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

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

ascorbic acid

120 mg

Biotin

150 microgram

borax

8.83 mg

calcium hydrogen phosphate

203.4 mg

calcium pantothenate

18 mg

chromic chloride hexahydrate

1.31 mg

colecalciferol

10 microgram

colloidal anhydrous silica

38.5 mg

cyanocobalamin

.05 mg

d-alpha-tocopherol

33.55 mg

ferrous fumarate

15.75 mg

folic acid

250 microgram

heavy magnesium oxide

66.4 mg

manganese sulfate monohydrate

3.08 mg

nicotinamide

30 mg

potassium iodide

131 microgram

pyridoxine hydrochloride

6 mg

retinol palmitate

1.375 mg

riboflavine

5 mg

selenomethionine

124 microgram

Tagetes erecta

33.2 mg

Public Summary

Page 2 of

Produced at 29.09.2019 at 05:28:46 AEST

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

Equivalent: Tagetes erecta (Dry)

249 mg

thiamine nitrate

3.5 mg

ubidecarenone

10 mg

zinc sulfate monohydrate

41.55 mg

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

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

Public Summary

Page 3 of

Produced at 29.09.2019 at 05:28:46 AEST

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

Similar products

Search alerts related to this product

Share this information