FORTARO

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

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Active ingredient:
calcifediol monohydrate
Available from:
DSM Nutritional Products Australia Pty Ltd
Authorization status:
Listed
Authorization number:
349938

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Public Summary

Summary for ARTG Entry:

349938

FORTARO

ARTG entry for

Medicine Listed

Sponsor

DSM Nutritional Products Pty Ltd

Postal Address

9 Moorebank Avenue, MOOREBANK, NSW, 2170

Australia

ARTG Start Date

27/11/2020

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 . FORTARO

Product Type

Single Medicine Product

Effective Date

30/11/2020

Permitted Indications

Maintain/support general health and wellbeing

Maintain/support healthy teeth

Maintain/support bone health

Aids/assists healthy bone development/growth/building

Help maintain/support bone mineralisation

Maintain/support heart health

Maintain/support immune system health

Maintain/support healthy immune system function

Maintain/support muscle health

Maintain/support muscle function

Maintain/support absorption of dietary (state vitamin/mineral/nutrient)

Maintain/support (state vitamin/mineral/nutrient) levels in the body

Helps prevent dietary (state vitamin/mineral/nutrient) deficiency

Maintain/support neuromuscular function

Maintain/support nervous system health

Indication Requirements

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

Product presentation must not imply or refer to serious cardiovascular conditions.

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

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.

Note: this requirement is not intended to apply where the indications referring to osteoporosis specified in column 2 of Table 2 of this instrument are also

used.

If product is indicated for supplementation, 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.

Standard Indications

Public Summary

Page 1 of

Produced at 11.01.2021 at 09:56:09 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

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Use in children under 9 years is not recommended.

Calcifediol may have similar effects to Vitamin D. Consult your health care professional before taking in combination with other medicines.

The medicine should not be taken in combination with supplements containing Vitamin D without medical advice (or words to that effect).

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

Active Ingredients

calcifediol monohydrate

.01 mg

Other Ingredients (Excipients)

calcium hydrogen phosphate dihydrate

croscarmellose sodium

crospovidone

dl-alpha-tocopherol

magnesium stearate

medium chain triglycerides

microcrystalline cellulose

silicon dioxide

sodium ascorbate

starch sodium octenyl succinate

sucrose

© 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 11.01.2021 at 09:56:09 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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