TCM Menopause Support-(GENG NIAN AN PIAN)

Australia - angielski - Department of Health (Therapeutic Goods Administration)

Kup teraz

Składnik aktywny:
Albizia julibrissin,Alisma plantago aquatica,Curculigo orchioides,Lycium barbarum,Ophiopogon japonicus,Oyster shell,Paeonia suffruticosa,Rehmannia glutinosa,Schisandra chinensis,Scrophularia ningpoensis,Triticum aestivum,Uncaria rhyncophylla,Wolfiporia cocos
Dostępny od:
Cathay Herbal Laboratories
Status autoryzacji:
Listed
Numer pozwolenia:
352257

Przeczytaj cały dokument

Public Summary

Summary for ARTG Entry:

352257

TCM Menopause Support-(GENG NIAN AN PIAN)

ARTG entry for

Medicine Listed

Sponsor

Cathay Herbal Laboratories

Postal Address

P O Box 6318, ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

24/12/2020

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.

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 . TCM Menopause Support-(GENG NIAN AN PIAN)

Product Type

Single Medicine Product

Effective Date

24/12/2020

Permitted Indications

Traditionally used in Chinese medicine to clear/cool/drain/purge/asthenic-heat/deficiency-heat in/of Yin deficiency pattern after eating in adults

Traditionally used in Chinese medicine to nourish yin/yin element/stratum in/of Yin deficiency pattern after eating in adults

Indication Requirements

If TCM terminology is used on medicine label, label statement: Talk to a TCM practitioner/health professional if you are unsure if this medicine is right for

you.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

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

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

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

Albizia julibrissin stem bark Extract dry concentrate

63 mg

Public Summary

Page 1 of

Produced at 11.01.2021 at 07:37:48 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: Albizia julibrissin (Dry)

504 mg

Alisma plantago aquatica rhizome Extract dry concentrate

32 mg

Equivalent: Alisma plantago aquatica (Dry)

512 mg

Curculigo orchioides rhizome Extract dry concentrate

63 mg

Equivalent: Curculigo orchioides (Dry)

252 mg

Lycium barbarum fruit Extract dry concentrate

32 mg

Equivalent: Lycium barbarum (Dry)

512 mg

Ophiopogon japonicus tuber Extract dry concentrate

32 mg

Equivalent: Ophiopogon japonicus (Dry)

512 mg

Oyster shell

63 mg

Paeonia suffruticosa root bark Extract dry concentrate

21 mg

Equivalent: Paeonia suffruticosa (Dry)

504 mg

Rehmannia glutinosa root Extract dry concentrate

63 mg

Equivalent: Rehmannia glutinosa (Dry)

756 mg

Schisandra chinensis fruit Extract dry concentrate

32 mg

Equivalent: Schisandra chinensis (Dry)

128 mg

Scrophularia ningpoensis root Extract dry concentrate

32 mg

Equivalent: Scrophularia ningpoensis (Dry)

755.2 mg

Triticum aestivum fruit Extract dry concentrate

63 mg

Equivalent: Triticum aestivum (Dry)

756 mg

Uncaria rhyncophylla stem Extract dry concentrate

63 mg

Equivalent: Uncaria rhyncophylla (Dry)

252 mg

Wolfiporia cocos fruiting body Extract dry concentrate

63 mg

Equivalent: Wolfiporia cocos (Dry)

756 mg

Other Ingredients (Excipients)

hypromellose

magnesium stearate

microcrystalline cellulose

purified talc

© 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 11.01.2021 at 07:37:48 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

Podobne produkty

Wyszukaj powiadomienia związane z tym produktem

Udostępnij tę informację