BA JI YIN YANG FANG-[Morinda Combination]

Main information

Documents

Localization

  • Available in:
  • BA JI YIN YANG FANG-[Morinda Combination]
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Listed
  • Authorization number:
  • 177567
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

177567

BA JI YIN YANG FANG-[Morinda Combination]

ARTG entry for

Medicine Listed

Sponsor

Cathay Herbal Laboratories

Postal Address

P O Box 6318,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

13/11/2010

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. BA JI YIN YANG FANG-[Morinda Combination]

Product Type

Single Medicine Product

Effective date

13/11/2010

Warnings

For practitioner dispensing only.

Keep out of reach of children (or words to that effect).

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

Standard Indications

Specific Indications

This Traditional Chinese medicine has been used traditionally to help as a SHEN [ kidney ] tonic. Supports the function of men & women.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Multiple containers

Not recorded

Not recorded

Not recorded

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Pill

Route of Administration

Oral

Visual Identification

Active Ingredients

Angelica polymorpha

25 mg

Public Summary

Page 1 of

Produced at 29.11.2017 at 11:18:34 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

Equivalent: Angelica polymorpha (Dry)

250 mg

Cornus officinalis

25 mg

Equivalent: Cornus officinalis (Dry)

250 mg

Dioscorea oppositifolia

62.5 mg

Equivalent: Dioscorea oppositifolia (Dry)

625 mg

Dipsacus japonicus

37.5 mg

Equivalent: Dipsacus japonicus (Dry)

375 mg

Epimedium brevicornu

12.5 mg

Equivalent: Epimedium brevicornu (Dry)

125 mg

Eucommia ulmoides

25 mg

Equivalent: Eucommia ulmoides (Dry)

250 mg

Loranthus parasiticus

37.5 mg

Equivalent: Loranthus parasiticus (Dry)

375 mg

Lycium chinense

25 mg

Equivalent: Lycium chinense (Dry)

250 mg

Morinda officinalis

12.5 mg

Equivalent: Morinda officinalis (Dry)

125 mg

Nelumbo nucifera

25 mg

Equivalent: Nelumbo nucifera (Dry)

250 mg

Paeonia lactiflora

25 mg

Equivalent: Paeonia lactiflora (Dry)

250 mg

Rehmannia glutinosa

37.5 mg

Equivalent: Rehmannia glutinosa (Dry)

375 mg

Rosa laevigata

25 mg

Equivalent: Rosa laevigata (Dry)

250 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 29.11.2017 at 11:18:34 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