SUPER

Main information

Documents

Localization

  • Available in:
  • SUPER AGE REW B Multi Plus
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216824
  • Last update:
  • 10-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216824

SUPER AGE REW B Multi Plus

ARTG entry for

Medicine Listed

Sponsor

Universal Pharmaceuticals Pty Ltd

Postal Address

PO Box 223,AUBURN, NSW, 1835

Australia

ARTG Start Date

1/11/2013

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.

The Ginkgo biloba leaf extract used in the manufacture of this medicine must comply with the requirement of Identification Test B of the monograph

Powdered Ginkgo Extract in the United States Pharmacopeia 32 - National Formulary 27 (USP32-NF27) as in force or existing from time to time. This

condition does not apply to powdered or dried leaf.

Products

1. SUPER AGE REW B Multi Plus

Product Type

Single Medicine Product

Effective date

4/02/2014

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 or assists in the maintenance of peripheral circulation.

May assist in maintaining peripheral circulation and promoting general health.

May assist blood circulation.

Non-vitamin active ingredients may improve stress adaptation.

Maintenance of healthy eyes.

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

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

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

Eyes formula. Assists visual fatigue and eye-strain.

May assist peripheral circulation.

To help maintain blood circulation to the peripheral areas of the body such as the legs, hands and feet.

Helps maintain normal blood/blood tonic (Note: These claims are appropriate for folic acid, vitamin B12 and iron, but must not imply anaemic conditions)

Beneficial during times of stress. [Warning S required]

Specific Indications

* Supports healthy immune function.

* Provides support to the immune system.

* Panax Ginseng may improve resistance to a wide variety of stressors.

Public Summary

Page 1 of

Produced at 22.11.2017 at 11:40:27 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

* Contains Panax Ginseng, which has an adaptogenic or tonic and nutritive action on the adrenal glands.

* Panax Ginseng is traditionally used as a tonic, and is frequently used today to relieve stress and maintain stamina.

* Panax Ginseng helps to improve stress adaptation.

* Panax Ginseng supports mental and physical performance and minimises the effects of stress.

* Used in herbal medicine to help improve mental and/or physical performance after periods of mental and/or physical exertion.

* Korean ginseng may help maintain stamina, energy and endurance.

* Helps maintain stamina, energy levels and endurance.

* May be useful in times of fatigue.

* Supports energy and vitality.

* Supports stamina and endurance.

* Helps perform in peak condition.

* Panax Ginseng is a powerful herbal tonic, which supports mental performance.

* Panax Ginseng has a long history of use in Traditional Chinese Medicine to maintain the body strength and support vitality and mental functions.

* Ganoderma lucidum has traditionally been used in Chinese medicine to support digestion.

* Contains important nutritional antioxidants/free radical scavengers.

* Contains antioxidant nutrients, which assist in protecting the body from the damaging effects of free radicals.

* Contains antioxidant nutrients, which assist in reducing the risk of cellular damage from free radicals.

* Protects the cells from free radical damage.

* Gingko has antioxidant activity and can therefore assist in protecting the body from the damaging effects of free radicals/oxidative damage.

* Aids mental alertness.

* Aids memory.

* Supports healthy memory and cognitive performance in adults.

* Supports attention and mental clarity.

* Gingko can help maintain healthy cognitive performance.

* Gingko has positive results on memory performance.

* Gingko supports/aids memory and alertness.

* Gingko supports memory in healthy people.

* Gingko may assist in recall and speed of information and processing.

* Supports/maintains healthy cognitive function.

* Supports/maintains healthy brain function.

* Used in herbal medicine to help support cognitive function.

* Supports cognitive function in adults.

* Supports/maintains the health of the nervous system.

* Contains nutrients essential for healthy nervous system function

* Contains nutrients required in the body for nerve cell function and muscle action.

* Supports neuromuscular function.

* Contains nutrients essential for protein, carbohydrate and fat metabolism.

* Supports healthy metabolism of proteins and fats in the body.

* Vitamin B6 assists in the metabolism protein/amino acids and fats.

* 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.

* Thiamine and nicotinamide are involved in energy metabolism/the production of energy in the body.

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

* Contains nutrients that assist in energy metabolism in the body.

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

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

Cordyceps sinensis

50 mg

Equivalent: Cordyceps sinensis (Dry)

200 mg

Crataegus monogyna

5 mg

Equivalent: Crataegus monogyna (Dry)

20 mg

Curcuma longa

5 mg

Equivalent: Curcuma longa (Dry)

100 mg

Epimedium sagittatum

40 mg

Equivalent: Epimedium sagittatum (Dry)

600 mg

Folic acid

75 microgram

Ganoderma lucidum

25 mg

Equivalent: Ganoderma lucidum (Dry)

500 mg

Ginkgo biloba

60 mg

Equivalent: Ginkgo biloba (Dry)

Lycium barbarum

150 mg

Equivalent: Lycium barbarum (Dry)

600 mg

Nicotinamide

7.5 mg

Public Summary

Page 2 of

Produced at 22.11.2017 at 11:40:27 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

Panax ginseng

50 mg

Equivalent: Panax ginseng (Dry)

500 mg

Poria cocos

40 mg

Equivalent: Poria cocos (Dry)

200 mg

pyridoxine hydrochloride

12 mg

Rehmannia glutinosa

41.67 mg

Equivalent: Rehmannia glutinosa (Dry)

250 mg

Reynoutria japonica

5 mg

Equivalent: Reynoutria japonica (Dry)

500 mg

Riboflavin

5 mg

Salvia miltiorrhiza

20 mg

Equivalent: Salvia miltiorrhiza (Dry)

200 mg

Schisandra chinensis

62.5 mg

Equivalent: Schisandra chinensis (Dry)

250 mg

Thiamine hydrochloride

5 mg

Ulmus rubra

5 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 22.11.2017 at 11:40:27 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