The Male Prenatal

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

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Active ingredient:
alpha lipoic acid,ascorbic acid,colecalciferol,d-alpha-tocopheryl acid succinate,levocarnitine tartrate,levomefolate calcium,selenomethionine,ubidecarenone,Withania somnifera,zinc citrate dihydrate
Available from:
Kin Fertility
Authorization status:
Listed
Authorization number:
350298

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Public Summary

Summary for ARTG Entry:

350298

The Male Prenatal

ARTG entry for

Medicine Listed

Sponsor

Kin Fertility

Postal Address

727 George Street, Level 3, Haymarket, NSW, 2000

Australia

ARTG Start Date

1/12/2020

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 . The Male Prenatal

Product Type

Single Medicine Product

Effective Date

1/12/2020

Permitted Indications

Antioxidant/Reduce free radicals formed in the body

Helps reduce/decrease free radical damage to body cells

Traditionally used in Ayurvedic medicine to rasayan/rejuvenative tonic

Enhance/promote energy levels

Traditionally used in Ayurvedic medicine to relieve feelings of general malaise/general debility

Traditionally used in Ayurvedic medicine to rejuvenating tonic

Vitamin D helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life

Aid/assist healthy red blood cell production

Maintain/support immune system health

Traditionally used in Ayurvedic medicine to adaptogen/Help body adapt to stress

Traditionally used in Ayurvedic medicine to maintain/support reproductive system health

Maintain/support reproductive system health

Maintain/support sperm health

Maintain/support sperm motility

Maintain/support testosterone level

Indication Requirements

Product presentation must not imply or refer to infertility.

Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not

replace a balanced diet.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

Product presentation must not imply or refer to chronic fatigue syndrome.

Product presentation must not imply or refer to serious cardiovascular conditions.

Indication only for use for medicines that contain vitamin D as an active ingredient. The medicines may only contain a maximum recommended daily dose

of 25 micrograms or less of vitamin D and as a minimum, also contain at least 25% of the RDI in the recommended daily dose of vitamin D.

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

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

Public Summary

Page 1 of

Produced at 11.01.2021 at 09:31:19 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

If Ayurvedic terminology is used on medicine label, label statement: Talk to a Ayurvedic 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).

Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not replace a balanced diet.

This product 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.

Do not take while on warfarin therapy without medical advice.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

alpha lipoic acid

50 mg

ascorbic acid

50 mg

colecalciferol

.025 mg

d-alpha-tocopheryl acid succinate

15 mg

Equivalent: d-alpha-tocopheryl acid succinate

18.15 IU

levocarnitine tartrate

44.12 mg

Equivalent: levocarnitine

30 mg

levomefolate calcium

433.3 microgram

Equivalent: levomefolic acid

400 microgram

selenomethionine

174 microgram

Equivalent: selenium

70 microgram

ubidecarenone

30 mg

Withania somnifera root Extract dry concentrate

150 mg

Equivalent: Withania somnifera (Dry)

zinc citrate dihydrate

77.77 mg

Equivalent: zinc

25 mg

Other Ingredients (Excipients)

Acacia

calcium hydrogen phosphate dihydrate

colloidal anhydrous silica

dl-alpha-tocopherol

Gelatin

magnesium stearate

maize starch

medium chain triglycerides

purified water

silicon dioxide

sodium lauryl sulfate

Public Summary

Page 2 of

Produced at 11.01.2021 at 09:31:19 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

sucrose

titanium dioxide

© 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 3 of

Produced at 11.01.2021 at 09:31:19 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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