Australian Pharma Co Royal Jelly 1000mg

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

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Active ingredient:
Royal jelly lyophilised
Available from:
Australian Pharma Co
Authorization status:
Listed
Authorization number:
346620

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Public Summary

Summary for ARTG Entry:

346620

Australian Pharma Co Royal Jelly 1000mg

ARTG entry for

Medicine Listed

Sponsor

Australian Pharma Co

Postal Address

4b Eton Street, North Perth, WA, 6006

Australia

ARTG Start Date

27/10/2020

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 . Australian Pharma Co Royal Jelly 1000mg

Product Type

Single Medicine Product

Effective Date

27/10/2020

Permitted Indications

Maintain/support general health and wellbeing

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Not to be taken by asthma and allergy sufferers [In 3 mm type, prominent on front]. AND This product contains royal jelly which has been reported to cause

severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers [in 1.5 mm type].

Not suitable for children.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

Royal jelly lyophilised

205 mg

Equivalent: 10-hydroxy-2-decenoic acid

12 mg

Public Summary

Page 1 of

Produced at 12.01.2021 at 12:02:20 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

Other Ingredients (Excipients)

calcium carbonate

d-alpha-tocopherol

Gelatin

glycerol

hydrogenated coconut oil

lecithin

purified water

Soya Oil

yellow beeswax

© 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 12:02:20 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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