Swisse

Main information

  • Trade name:
  • Swisse Ultiboost Relax & Sleep
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Swisse Ultiboost Relax & Sleep
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219917
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219917

Swisse Ultiboost Relax & Sleep

ARTG entry for

Medicine Listed

Sponsor

Swisse Wellness Pty Ltd

Postal Address

111 Cambridge Street,Collingwood, VIC, 3066

Australia

ARTG Start Date

6/02/2014

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. Swisse Ultiboost Relax & Sleep

Product Type

Single Medicine Product

Effective date

9/03/2016

Warnings

If symptoms persist consult your healthcare practitioner (or words to that effect).

Standard Indications

Specific Indications

Aids, assists or helps in the maintenance of general wellbeing.

Passionflower is traditionally used in Western Herbal Medicine to help/in the relief of symptoms associated with nervous restlessness/ in times of stress

and tension. Has sedative properties to assist with/support restful natural sleep/ingredients to support restful sleep.

Passionflower is used in traditional Western Herbal Medicine to help relieve/calm tenseness, restlessness and irritability with difficulty in falling

asleep/encourage restful sleep/support falling asleep.

Passionflower is used in traditional Western Herbal Medicine to help/ with gastrointestinal symptoms associated with nervousness/settle the stomach

during times of nervousness.

Hops is used in traditional Western Herbal Medicine to help/ in the relief of sleeplessness/encourage/support a natural restful sleep/with a restful sleep.

Hops is used in traditional Western Herbal Medicine to help with relaxation and aid in the relief nervous tension/to calm nervous tension.

Lemon balm is used in traditional Western Herbal Medicine to help/ relieve

mild symptoms of mental stress and to aid sleep/help calm the mind during times of stress and support restful sleep.

Lemon balm is used in traditional Western Herbal Medicine to/ help with the

symptomatic relief of mild gastrointestinal symptoms including bloating and flatulence/soothe and support the stomach and to settle bloating and

flatulence.

Lemon balm is used in traditional Western Herbal Medicine as a carminative/soothing agent for gastrointestinal disorders/discomfort, and as a sedative

to help relieve nervous disturbances of sleep/to help calm and soothe the nerves for a restful night's sleep.

Lemon balm is used in traditional Western Herbal Medicine/as a sleep aid (in cases of restlessness or insomnia due to mental stress)/to calm the mind

and support a restful night's sleep.

Lemon balm is used in traditional Western herbal medicine to help/ relieve digestive disturbances, such as indigestion/ support normal healthy digestion

and to soothe and settle the stomach.

Magnesium helps to maintain/support good health/general health.

Magnesium helps to maintain healthy muscle function.

Magnesium is important for normal/healthy muscle function.

Sleep is required to restore the body and mind.

Magnesium supports muscle relaxation by competitively binding to receptor sites normally reserved for calcium, which is the mineral that causes muscles

to contract. A depletion of Magnesium may lead to muscle cramps and spasms/Magnesium may provide support for muscle cramps and spasms.

Calcium and magnesium work together to cause the contraction and relaxation of muscles. Magnesium may provide support for muscle cramps and

spasms/ Increased calcium and a depletion of magnesium may lead to muscle cramps.

Public Summary

Page 1 of

Produced at 26.11.2017 at 03:13:35 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

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Humulus lupulus

50 mg

Equivalent: Humulus lupulus (Dry)

500 mg

Magnesium citrate

324.88 mg

Melissa officinalis

33.33 mg

Equivalent: Melissa officinalis (Dry)

750 mg

Passiflora incarnata

150 mg

Equivalent: Passiflora incarnata (Dry)

1.5 g

© 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 03:13:35 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

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

There are no news related to this product.