BLACKMORES MULTIVITAMIN FOR TEEN BOYS

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

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Active ingredient:
ascorbic acid,Biotin,calcium carbonate,calcium pantothenate,chromium picolinate,colecalciferol,cyanocobalamin,d-alpha-tocopherol,ferrous fumarate,folic acid,heavy magnesium oxide,high selenium yeast,natural fish oil,nicotinamide,potassium iodide,pyridoxine hydrochloride,retinol palmitate,riboflavin,thiamine nitrate,zinc sulfate monohydrate
Available from:
Blackmores Ltd
Authorization status:
Listed
Authorization number:
322736

Public Summary

Summary for ARTG Entry:

322736

BLACKMORES MULTIVITAMIN FOR TEEN BOYS

ARTG entry for

Medicine Listed

Sponsor

Blackmores Ltd

Postal Address

PO Box 1725,WARRIEWOOD, NSW, 2102

Australia

ARTG Start Date

5/09/2019

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 TEEN BOYS

Product Type

Single Medicine Product

Effective date

5/09/2019

Permitted Indications

Maintain/support energy production

Maintain/support healthy growth and development

Maintain/support general health and wellbeing

Aids/assists healthy bone development/growth/building

Maintain/support healthy immune system function

Maintain/support muscle health

Maintain/support muscle function

Support healthy stress response in the body

Maintain/support cognitive function/mental function

Maintain/support brain/central nervous system development

Maintain/support nervous system function

Maintain/support skin health

Indication Requirements

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

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 serious immunological diseases.

Product presentation must not imply or refer to neurological conditions or developmental delays.

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.

Public Summary

Page 1 of

Produced at 29.09.2019 at 05:16:45 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

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

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

NB: Includes bisulfate and metabisulfite salts and sulfur dioxide.

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.

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

40 mg

Biotin

25 microgram

calcium carbonate

12.5 mg

calcium pantothenate

6.54 mg

chromium picolinate

282 microgram

colecalciferol

5 microgram

cyanocobalamin

.002 mg

d-alpha-tocopherol

10.1 mg

ferrous fumarate

15.7 mg

folic acid

200 microgram

heavy magnesium oxide

88 mg

high selenium yeast

50 mg

natural fish oil

420 mg

nicotinamide

16 mg

potassium iodide

197 microgram

pyridoxine hydrochloride

1.3 mg

retinol palmitate

1.29 mg

riboflavin

1.3 mg

thiamine nitrate

1.48 mg

zinc sulfate monohydrate

41.6 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 2 of

Produced at 29.09.2019 at 05:16:45 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

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