Propolis 7000 Advanced Formula

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

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Active ingredient:
d-alpha-tocopheryl acid succinate,Propolis dry extract
Available from:
Proudex Australia Pty Ltd
Authorization status:
Listed
Authorization number:
345843

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Public Summary

Summary for ARTG Entry:

345843

Propolis 7000 Advanced Formula

ARTG entry for

Medicine Listed

Sponsor

Proudex Australia Pty Ltd

Postal Address

Unit 3 / 17-21 Bowden Street, ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

13/10/2020

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 . Propolis 7000 Advanced Formula

Product Type

Single Medicine Product

Effective Date

13/10/2020

Permitted Indications

Antioxidant/Reduce free radicals formed in the body

Maintain/support general health and wellbeing

Anti-inflammatory/relieve inflammation

Helps enhance/improve/promote immune system function

Maintain/support healthy immune system function

Helps decrease/reduce/relieve the severity of symptoms of common colds and flu

Indication Requirements

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

Product presentation must not imply or refer to serious immunological diseases.

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

Label statement: Adults only, OR Not to be used in children under 2 years of age without medical advice (or words to that effect).

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Adults only. OR Not to be used in children under two years of age without medical advice (or words to that effect).

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

WARNING: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Public Summary

Page 1 of

Produced at 12.01.2021 at 12:57:34 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

Components

1 . Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

d-alpha-tocopheryl acid succinate

6.2 mg

Propolis dry extract

350 mg

Equivalent: lead

350 ng

Equivalent: Propolis

Other Ingredients (Excipients)

calcium hydrogen phosphate dihydrate

Carnauba Wax

carob pod

colloidal anhydrous silica

croscarmellose sodium

crospovidone

hypromellose

iron oxide black

iron oxide red

iron oxide yellow

macrogol 400

magnesium stearate

microcrystalline cellulose

povidone

© 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 12.01.2021 at 12:57:34 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

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