Vitamore

Main information

  • Trade name:
  • Vitamore Hair Skin and Nail capsules (V2)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Vitamore Hair Skin and Nail capsules (V2)
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222851
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222851

Vitamore Hair Skin and Nail capsules (V2)

ARTG entry for

Medicine Listed

Sponsor

Nature's Care Manufacture Pty Limited

Postal Address

5 Minna Close,BELROSE, NSW, 2085

Australia

ARTG Start Date

28/04/2014

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. Vitamore Hair Skin and Nail capsules (V2)

Product Type

Single Medicine Product

Effective date

28/04/2014

Warnings

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

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

Standard Indications

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

Specific Indications

Promotes the growth of strong,healthy nails. Helps to strengthen soft brittle nails. May assist in the management of brittle nails by increasing the

thickness of the fingernails.,Assists in the maintenance/supports healthy skin. Supports healthy skin renewal processes.Contains nutrients that are

required for the proper integrity of the skin, Vitamin C is necessary for the maintenance of healthy skin. Assists in the healing and repair of the skin.

Supports healthy skin and the healing of minor wounds.,Contains nutrients that are involved in the formation of collagen, a structural protein, in the body.

Contains nutrients that play a role in the synthesis of collagen and elastin in the body. Vitamin C is necessary for the manufacture of collagen in the

body. Vitamin C plays a role in collagen formation.,For healthy skin, hair and nails. Contains nutrients required for the healthy growth of the skin, hair and

nails.,Contains antioxidant nutrients. Contains important antioxidants, which help to protect the body from the damaging effects of free radicals. Vitamin

C is an important nutritional antioxidant/free radical scavenger. As an antioxidant, vitamin C assists in protecting the body from the damaging effects of

free radicals. Vitamin C is a potent antioxidant that can reduce the risk of cellular damage from free radicals.,Contains nutrients which support healthy

immune system function. Contains nutrients that are involved in immune mechanisms in the body. Vitamin C is essential for the proper function of the

immune system. Maintains a normal/healthy immune system. Vitamin C plays a vital role in many immune mechanisms.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Public Summary

Page 1 of

Produced at 26.11.2017 at 10:48:31 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

Visual Identification

Active Ingredients

Biotin

2.6 mg

calcium ascorbate

60.52 mg

Ferrous fumarate

16.01 mg

Silicon dioxide

86.56 mg

Zinc gluconate

195.3 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 26.11.2017 at 10:48:31 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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