Bronc)X

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

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Active ingredient:
Eriobotrya japonica,Morus alba,Myrica cerifera,Peucedanum praeruptorum,Platycodon grandiflorus,Stemona sessilifolia
Available from:
BlueSkyGreenEarth Herbs Pty Ltd
Authorization status:
Listed
Authorization number:
351354

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Public Summary

Summary for ARTG Entry:

351354

Bronc)X

ARTG entry for

Medicine Listed

Sponsor

BlueSkyGreenEarth Herbs Pty Ltd

Postal Address

PO Box 269, ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

9/12/2020

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 . Bronc)X

Product Type

Single Medicine Product

Effective Date

18/12/2020

Permitted Indications

Traditionally used in Chinese medicine to dispel/expel/extinguish/disperse/clear lung-heat

Traditionally used in Chinese medicine to clear/expel/dissolve/resolve Phlegm

Traditionally used in Chinese medicine to decrease/reduce/relieve cough

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.

Product presentation must not imply or refer to disease in any body organ.

Product presentation must not imply or refer to serious forms of respiratory disorders/diseases, such as: asthma, pneumonia, COAD, COPD, influenza.

Label statement: If symptoms persist, talk to your health professional.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

(If medicine contains one sugar) contains [insert name of sugar] OR (If medicine contains two or more sugars) Contains sugars [or words to that effect].

(If medicine contains one benzoate) Contains [insert name of benzoate] Or (If medicine contains two or more benzoates) Contains benzoates [or words to

that effect].

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Oral Liquid

Public Summary

Page 1 of

Produced at 11.01.2021 at 08:52:57 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

Route of Administration

Oral

Visual Identification

Active Ingredients

Eriobotrya japonica leaf Extract liquid concentrate

131 mg/mL

Equivalent: Eriobotrya japonica (Dry)

131 mg/mL

Morus alba root bark Extract liquid concentrate

9 mg/mL

Equivalent: Morus alba (Dry)

9 mg/mL

Myrica cerifera fruit Oil essential

.12 mg/mL

Peucedanum praeruptorum root and rhizome Extract liquid concentrate

14 mg/mL

Equivalent: Peucedanum praeruptorum (Dry)

14 mg/mL

Platycodon grandiflorus root Extract liquid concentrate

9 mg/mL

Equivalent: Platycodon grandiflorus (Dry)

9 mg/mL

Stemona sessilifolia root Extract liquid concentrate

23 mg/mL

Equivalent: Stemona sessilifolia (Dry)

23 mg/mL

Other Ingredients (Excipients)

benzoic acid

citric acid monohydrate

menthol

purified water

sucrose

© 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 08:52:57 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

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