Bioglan Calming Spray

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

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Active ingredient:
calcium pantothenate,cyanocobalamin,nicotinamide,pyridoxine hydrochloride,Passiflora incarnata,Withania somnifera
Available from:
Natural Bio Pty Limited
Authorization status:
Listed
Authorization number:
322667

Public Summary

Summary for ARTG Entry:

322667

Bioglan Calming Spray

ARTG entry for

Medicine Listed

Sponsor

Natural Bio Pty Limited

Postal Address

PO Box 384,MONA VALE, NSW, 1660

Australia

ARTG Start Date

4/09/2019

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. Bioglan Calming Spray

Product Type

Single Medicine Product

Effective date

4/09/2019

Permitted Indications

Antioxidant/Reduce free radicals formed in the body

Helps reduce/decrease free radical damage to body cells

Maintain/support energy levels

Relieve weariness/tiredness/fatigue/feeling of weakness

Maintain/support general health and wellbeing

Maintain/support immune system health

Maintain/support healthy immune system function

Helps decrease/reduce homocysteine levels

Maintain/support (state vitamin/mineral/nutrient) levels in the body

Support healthy stress response in the body

Traditionally used in Western herbal medicine to decrease/reduce/relieve restlessness/excess nervous energy

Maintain/support brain function

Maintain/support brain health

Aid/assist/helps synthesis of neurotransmitters

Maintain/support nervous system health

Traditionally used in Western herbal medicine to calmative/nervous system relaxant

Maintain/support nervous system function

Support healthy emotional/mood balance

Traditionally used in Western herbal medicine to decrease/reduce/relieve sleeplessness

Indication Requirements

Public Summary

Page 1 of

Produced at 29.09.2019 at 05:24:38 AEST

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

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

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

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

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

If product is indicated for supplementation, 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

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

(If the medicine contains one sorbate) Contains [insert name of sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to

that effect].

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Spray

Route of Administration

Oral

Visual Identification

Active Ingredients

calcium pantothenate

2.42 mg/mL

cyanocobalamin

.71 microgram/mL

nicotinamide

6.04 mg/mL

Passiflora incarnata

48.36 mg/mL

Equivalent: Passiflora incarnata (Dry)

241.8 mg/mL

pyridoxine hydrochloride

1.21 mg/mL

Withania somnifera

9.074 mg/mL

Equivalent: Withania somnifera (Dry)

362.96 mg/mL

© 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 29.09.2019 at 05:24:38 AEST

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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