Bilberry

Main information

Documents

Localization

  • Available in:
  • Bilberry Vision 10000
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217938
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217938

Bilberry Vision 10000

ARTG entry for

Medicine Listed

Sponsor

Bio Nourish Pty Ltd

Postal Address

PO Box 216,TERRIGAL, NSW, 2260

Australia

ARTG Start Date

2/12/2013

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. Bilberry Vision 10000

Product Type

Single Medicine Product

Effective date

19/11/2015

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.

WARNING: May be dangerous if taken in large amounts or for a long period. OR WARNING: Contains zinc which may be dangerous if taken in large

amounts or for a long period (or words to that effect).

Standard Indications

May assist blood circulation.

Maintain health of capillaries.

Protects capillaries.

Maintenance of healthy eyes.

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

Eyes formula. Support of healthy eye function.

May help reduce the oxidation of LDL cholesterol.

Eyes formula. Helps eyes to adapt to variations in light intensity.

Specific Indications

* Supports/maintains normal eye function.

* Supports healthy eye function and vision.

* Supports the health and function of the macular area of the retina and lens of the eye/structures of the eye.

* Assists in maintaining the health and function of the macular area of the retina and lens of the eye/structures of the eye.

* May assist in improving vision in poor light.

* Supports and/or maintains normal eye function/night vision.

* May assist in improving night vision/visual perception at night.

* Zinc is important for healthy eye function.

* Zinc plays an important role in the visual system.

* Maintains a healthy cardiovascular system.

* Bilberry has potent antioxidant activity and can therefore help to protect the body from free radical damage.

* The antioxidant activity of Bilberry can help to protect against oxidative stress.

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:53:26 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

* Antioxidants are nutrients that decrease the risk of cell damage attributed to 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.

* Vitamin C supports connective tissue formation.

* Contains vitamin C, which is necessary for the manufacture of collagen in the body.

* Vitamin C plays a role in collagen formation.

* Vitamin C is necessary for minor wound healing.

* Vitamin C is necessary for the maintenance of healthy skin.

* Assists in the healing and repair of the skin.

* Zinc is required for protein synthesis and cell growth.

* Supports healthy skin renewal processes.

* Supports the health and maintenance of the skin.

* Zinc helps to maintain healthy skin function and repair.

* Zinc assists in the maintenance of healthy skin.

* Supports healthy skin, hair and nails.

* Contains nutrients that are essential for the proper function of the immune system.

* Maintains a normal/healthy immune system.

* Contains nutrients that maintain the immune system.

* Contains nutrients that play a vital role in many immune mechanisms.

* Zinc supports healthy immune function.

* Zinc supports the healthy function of the immune system.

* Zinc is important for the health and function of the immune system.

* Zinc is an important nutrient for a healthy immune response.

* Contains nutrients that are involved in normal blood sugar regulation and carbohydrate metabolism in healthy people.

* Chromium is an essential nutrient required for carbohydrate, lipid and protein metabolism.

* Vitamin C may reduce susceptibility to bruising.

* Lifestyle factors such as stress and cigarettes may increase the body's vitamin C requirements.

* Chromium aids in the transport of glucose into the cells.

* Chromium facilitates the uptake of glucose into the cells.

* Contains chromium, which is a main component of glucose tolerance factor.

* Zinc supports healthy hormonal balance.

* Contains nutrients that are involved in hormone synthesis and modulation.

* Provides nutrients that are essential in the body for the production of energy.

* Riboflavin functions as a component of important enzymes that are involved in energy production.

* Riboflavin is crucial in the production of energy in the body.

* Contains nutrients that play an essential role in the production of energy in the body.

* Contains nutrients that play an essential role in the production of ATP/cellular energy.

* Contains lutein, which is found in high concentrations in the eye where it filters out blue light, and therefore helps to protect the structures of the eye.

* Contains lutein, which can assist in inhibiting damage to the photoreceptor cell layer.

* Contains lutein, which helps to protect ocular tissues from photodamage.

* Lutein is found in the macula and is a major component of macular pigment.

* Higher macular pigment density is associated with the preservation of visual sensitivity.

* Lutein supplementation may support healthy macular pigment density.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Ascorbic acid

250 mg

Betacarotene

3 mg

chromic chloride hexahydrate

256 microgram

Citrus bioflavonoids extract

50 mg

d-alpha-Tocopheryl acid succinate

61.98 mg

Euphrasia officinalis

20.84 mg

Equivalent: Euphrasia officinalis (Dry)

100 mg

Glutamine

20 mg

lutein

6 mg

Nicotinamide

10 mg

Riboflavin

20 mg

rutoside

50 mg

Taurine

50 mg

Vaccinium myrtillus

100 mg

Equivalent: Vaccinium myrtillus (Fresh)

10 g

Zinc gluconate

104.53 mg

Public Summary

Page 2 of

Produced at 23.11.2017 at 12:53:26 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

© 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 23.11.2017 at 12:53:26 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