BLOOMS

Main information

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Localization

  • Available in:
  • BLOOMS V-DRIVE MEN
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214848
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214848

BLOOMS V-DRIVE MEN

ARTG entry for

Medicine Listed

Sponsor

Phytologic Holdings Pty Ltd

Postal Address

PO Box 6193,Alexandria, NSW, 2015

Australia

ARTG Start Date

20/09/2013

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.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted

in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office

of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors

of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified

of the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

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. BLOOMS V-DRIVE MEN

Product Type

Single Medicine Product

Effective date

6/12/2016

Warnings

WARNING: May be dangerous if taken in large amounts or for a long period. OR WARNING: Contains zinc which may be dangerous if taken in large

amounts or for a long period (or words to that effect).

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

Standard Indications

For vitamin (may state the vitamin) supplementation.

For mineral (may state the mineral) supplementation.

Aids, assists or helps in the maintenance or improvement of general well-being.

May assist in the maintenance of normal healthy blood sugar/glucose levels in healthy individuals.

May assist in the maintenance of normal healthy blood sugar/glucose balance in healthy individuals.

Specific Indications

Can assist to maintain normal healthy testosterone levels in men.

Can have an overall positive effect on libido in healthy adult males.

Can have a positive effect on frequency of sexual activity.

Can have a positive effect on sexual cognition, sexual arousal increases sexual activity and satisfaction with orgasm in healthy adult males.

Can have a positive effect on muscle strength, energy and wellbeing in healthy adult males.

Improve body composition.

Fenugreek contains steroidal saponins, sapogenins and furostanol saponins, which are important precursors for the synthesis of a number of sex

hormones.

Reduces protein catabolism.

Assists with improved body composition (increased lean body mass, enhanced muscle, diminished visceral fat), mood, cognition, and sexual function.

May help support glucose metabolism in normal, healthy individuals.

Improvement in general energy and wellbeing.

Improvements in libido, recovery time and quality of sexual performance.

Helps increase muscle mass, energy and stamina and serum testosterone levels.

Magnesium is a mineral essential to human nutrition with a wide range of biological roles. It is involved in over 300 metabolic processes and is required

for all major biological process, including the production of cellular energy and the synthesis of nucleic acids and proteins. It is also important for the

electrical stability of cells, to maintain the integrity of membranes, support muscle contraction, and among other things, nerve conduction and the

regulation of vascular tone.

Public Summary

Page 1 of

Produced at 26.11.2017 at 09:18:56 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

Vitamin B6 is involved in the metabolism of amino acids and glycogen, the synthesis of nucleic acids, hemoglobin, sphigomyelin and other sphigolipids,

and the synthesis of the neurotransmitters serotonin, dopamine, norepinephrine and gamma-aminobutyric acid (GABA).

Vitamin B6 supports immune system health and is important for energy production.

The active form of vitamin B6 plays a role in the regulation of steroid hormone activity.

Zinc has a wide range of biological roles and is an essential element in human nutrition.

Involved in more than 200 zinc metalloenzymes that have been identified in biological systems.

Zinc is vital for growth and developmenty, sexual maturation and reproduction, dark vision adaptation, olfactory and gustatory activity, maintenance of

blood glucose levels (in normal, healthy individuals) and for a variety of host immune defences, among other things.

Zinc is involved in sperm formation and testosterone metabolism. Zinc deficiency may be associated with oligospermia.

Virility, vitality and vigour.

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

magnesium aspartate

200.9 mg

pyridoxine hydrochloride

6 mg

Trigonella foenum-graecum

300 mg

Equivalent: Trigonella foenum-graecum (Dry)

9.9 g

zinc amino acid chelate

75 mg

© 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 26.11.2017 at 09:18:56 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