REDORMIN

Main information

  • Trade name:
  • REDORMIN
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • REDORMIN
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217083
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217083

REDORMIN

ARTG entry for

Medicine Listed

Sponsor

SFI Australasia

Postal Address

PO Box 1027,CROWS NEST, NSW, 1585

Australia

ARTG Start Date

11/11/2013

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. REDORMIN

Product Type

Single Medicine Product

Effective date

8/10/2014

Warnings

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

Standard Indications

Relief of insomnia. [Warning S required]

Relief of sleeplessness. [Warning S required]

Specific Indications

[1] Traditionally used in Herbal Medicine as a sleep aid to help promote sleep.

[2] Traditionally used in Herbal Medicine as a mild sedative and/or sleep aid (hypnotic).

[3] Traditionally used in Herbal Medicine as a sleep aid (in cases of restlessness or insomnia due to stress).

[4] Relief of insomnia so that you obtain a quality night's sleep. Helps improve sleep quality without groggy after effects. Allowing you to wake refreshed.

[5] Helps to promote sleep/Used as a sleep aid/Helps you to fall asleep

[6] May help to restore normal/healthy sleep patterns. Helps restore normal (healthy) sleep patterns (rhythms, cycle) in 2 weeks / Helps regulate sleep

patterns / A clinical trial showed normal (healthy) sleep patterns were restored after 2 weeks of ReDormin / to help you regain your normal/healthy sleep

patterns (rhythms) / Helps relieve disturbed sleep patterns / Promotes healthy sleep patterns

[7] May increase the time spent in the deeper restorative stages of the sleep cycle/ Promotes a restful quality sleep / Helps achieve a restorative sleep.

Supports your body to get the quality sleep it needs.

[8] Helps to shorten time to get to sleep (Sleep latency) Helps you to fall asleep quicker (faster) / Helps you fall asleep faster

[9] Helps you to stay asleep for longer/ May help reduce waking during the night / Helps you stay asleep longer / Increases sleep duration

[10] Used for sleep problems related to nervous tension, irritability, excitability, mild anxiety restlessness / Assists in relieving insomnia associated with

nervousness, anxiety or stress / For relief of insomnia due to mental worry / nervous tension / overactive mind/ racing thoughts / Helps to calm, relax and

unwind

[11] Assists with jetlag and sleep related disturbance due to travel (disruption to circadian sleep rhythm & adenosine mechanism)

[12] Relief of insomnia.

[13] Relief of sleeplessness.

[14] May help maintain or improve normal concentration the next day.

[15] Valerian and Hops act on adenosine and melatonin to reduce sleep latency and normalise circadium sleep phases.

[16] Helps relieve sleeplessness and insomnia without rebound insomnia.

Additional Product information

Public Summary

Page 1 of

Produced at 26.11.2017 at 06:58:06 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

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

60 mg

Equivalent: Humulus lupulus (Dry)

360 mg

Valeriana officinalis

250 mg

Equivalent: Valeriana officinalis (Dry)

1.25 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 06:58:06 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.