Prorox

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

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Active ingredient:
colecalciferol,Crateva magna,Equisetum arvense,Lindera strychnifolia,selenomethionine,Serenoa repens,zinc citrate
Available from:
Seipel Group Pty Ltd
Authorization status:
Listed
Authorization number:
346485

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Public Summary

Summary for ARTG Entry:

346485

Prorox

ARTG entry for

Medicine Listed

Sponsor

Seipel Group Pty Ltd

Postal Address

PO Box 3449, NEWMARKET, QLD, 4051

Australia

ARTG Start Date

23/10/2020

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 . Prorox

Product Type

Single Medicine Product

Effective Date

23/10/2020

Permitted Indications

Maintain/support connective tissue health

Help maintain/support healthy prostate function

Maintain/support healthy bladder function

Maintain/support bladder health

Decrease/reduce/relieve urinary incontinence associated with medically diagnosed overactive bladder

Decrease/reduce/relieve urinary urgency associated with medically diagnosed overactive bladder

Maintain/support kidney function

Indication Requirements

Product presentation must not imply or refer to serious genitourinary conditions like Benign Prostatic Hypertrophy, erectile dysfunction or hormone therapy.

Label statement: If symptoms persist or worsen talk to your medical practitioner.

Product presentation must not imply or refer to kidney disease.

Product presentation must only refer to medically diagnosed overactive bladder.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be

exceeded.

If symptoms persist consult a medical practitioner (or healthcare professional) (or words to that effect).

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Public Summary

Page 1 of

Produced at 12.01.2021 at 12:15:18 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

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

colecalciferol

12.5 microgram

Crateva magna stem bark Extract dry concentrate

120 mg

Equivalent: Crateva magna (Dry)

Equisetum arvense herb Extract dry concentrate

150 mg

Equivalent: Equisetum arvense (Dry)

1.5 g

Lindera strychnifolia root Extract dry concentrate

150 mg

Equivalent: Lindera strychnifolia (Dry)

1.5 g

selenomethionine

134 microgram

Equivalent: selenium

27.5 microgram

Serenoa repens fruit flesh Extract dry concentrate

640 mg

Equivalent: Serenoa repens (Dry)

6.4 g

zinc citrate

17.2 mg

Equivalent: zinc

5.5 mg

Other Ingredients (Excipients)

calcium hydrogen phosphate

hypromellose

magnesium stearate

maltodextrin

silicon dioxide

starch sodium octenyl succinate

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 12.01.2021 at 12:15:18 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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