Main information

  • Trade name:
  • Mediherb Tissue Regenex
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug



  • Available in:
  • Mediherb Tissue Regenex
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221663
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Mediherb Tissue Regenex

ARTG entry for

Medicine Listed


Integria Healthcare Australia Pty Ltd

Postal Address



ARTG Start Date


Product category




Approval area

Listed Medicines


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


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.


1. Mediherb Tissue Regenex

Product Type

Single Medicine Product

Effective date



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

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).

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

For practitioner dispensing only.

Standard Indications

Maintain health of capillaries.

May assist blood circulation.

May assist peripheral circulation.

Aids or assists in the maintenance of peripheral circulation.

Specific Indications

Gotu kola is used in traditional Indian medicine (Ayurveda) for various kin complaints, such as eczema and psoriasis.

May assist in relieving symptoms of poor circulation, such as swelling, heaviness and tingling.

Standardised Ginkgo extract is an antioxidant and supports healthy blood flow.

Grape seed procyanidins help stabilise capillary walls.

Supports the formation connective tissue, such as of collagen.

Supports a healthy immune system / Helps to maintain immune function.

Zinc and vitamin C participate in the antioxidant defence mechanism of the body.

Antioxidant / Has anti-oxidizing effect.

Grape Seed may alleviate symptoms associated with poor circulation.

Used in traditional Indian medicine (Ayurvedia) as a brain tonic.

Gotu kola is used in traditional herbal medicine to aid wound healing.

Helps in wound healing.

Public Summary

Page 1 of

Produced at 26.11.2017 at 12:50:24 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 for contact information

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule


1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration


Visual Identification

Active Ingredients

Ascorbic acid

105 mg

Centella asiatica

250 mg

Equivalent: Centella asiatica (Dry)

2.5 g

Ginkgo biloba

20 mg

Vitis vinifera

30 mg

Equivalent: Vitis vinifera (Dry)

3.6 g

Zinc gluconate

86 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

Public Summary

Page 2 of

Produced at 26.11.2017 at 12:50:24 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 for contact information