aloeBERRY

Main information

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

Documents

Localization

  • Available in:
  • aloeBERRY
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211781
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211781

aloeBERRY

ARTG entry for

Medicine Listed

Sponsor

Kadac Pty Ltd

Postal Address

0134 Argus Street,CHELTENHAM, VIC, 3192

Australia

ARTG Start Date

5/07/2013

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. aloeBERRY

Product Type

Single Medicine Product

Effective date

5/07/2013

Warnings

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

(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].

(If medicine contains one benzoate) Contains [insert name of benzoate] Or (If medicine contains two or more benzoates) Contains benzoates [or words

to that effect].

Standard Indications

May assist in the management of medically diagnosed irritable bowel syndrome

For the symptomatic relief of medically diagnosed irritable bowel syndrome

Treatment of mild digestive disorders. [Warning S required]

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

Aids digestion.

Helps maintain healthy digestive function.

Specific Indications

A digestive tonic soothing to the lining of the stomach and intestines.

Supports/maintains the health of the digestive tract.

Supports/maintains gastrointestinal health and function.

Supports the health and function of the immune system.

Helps to maintain healthy immune function.

Aloe has antioxidant or free radical scavenging activity.

The antioxidant activity of aloe is beneficial in helping to protect the tissues against oxidative damage.

Aloe barbadensis has a long history of use in traditional Chinese Medicine for the relief of bowel irregularity, irritability and insomnia. In traditional

Chinese medicine, Aloe barbadensis is used to clear excess liver heat. This action of the herb may help to relieve symptoms of abdominal pain,

headache, dizziness, irritability, bowel irregularity and fever.

Aloe barbadensis has a long history of use in the Chinese Medicine systems for ridding intestinal parasites and strengthening the stomach.

Aloe juice enhances absorption of vitamins E and C.

The pure 'inner gel' of the Aloe barbadensis plant contains numerous plant phytonutrients and active components such as saponins and

polysaccharides, essential for cell growth and renewal.

Public Summary

Page 1 of

Produced at 27.11.2017 at 01:00:57 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

Aloe vera contains a range of essential vitamins and minerals and well as phytonutrients.

Supports daily nutritional intake.

Blackcurrants are a source of antioxidant substances called anthocyanins.

Blackcurrants are a potent antioxidant and therefore assist in protecting the body from the damaging effects of free radicals.

Blackcurrants have antioxidant, or free radical scavenging activity.

Blackcurrants are a rich source of antioxidants.

The free radical scavenging activity of blackcurrants may provide protection against oxidative damage.

Blackcurrants are a good source of Vitamin C

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Oral Liquid

Route of Administration

Oral

Visual Identification

Active Ingredients

Aloe vera

946 mg/mL

Ribes nigrum

47.5 mg/mL

Equivalent: Ribes nigrum (Fresh)

712.5 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 27.11.2017 at 01:00:57 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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Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Verapamil / trandolapril, decision type: , therapeutic area: , PIP number: P/0162/2018

Opinion/decision on a Paediatric investigation plan (PIP): Verapamil / trandolapril, decision type: , therapeutic area: , PIP number: P/0162/2018

Opinion/decision on a Paediatric investigation plan (PIP): Verapamil / trandolapril, decision type: , therapeutic area: , PIP number: P/0162/2018

Europe - EMA - European Medicines Agency

15-8-2018

Scientific guideline:  Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open

Scientific guideline: Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open

This document intends to cover the general quality aspects of herbal medicinal products for human and veterinary use, including traditional herbal medicinal products for human use. It describes the special problems of herbal medicinal products and the differences between medicinal products containing chemically defined active substances.

Europe - EMA - European Medicines Agency

26-7-2018

Regulatory and procedural guideline:  EudraVigilance release notes v.1.17

Regulatory and procedural guideline: EudraVigilance release notes v.1.17

This document lists and briefly describes the following areas for the releases of EVWEB starting with the release on 22 November 2017.

Europe - EMA - European Medicines Agency

15-6-2018

Regulatory and procedural guideline:  EudraVigilance release notes v.1.15

Regulatory and procedural guideline: EudraVigilance release notes v.1.15

This document lists and briefly describes the following areas for the releases of EVWEB starting with the release on 22 November 2017.

Europe - EMA - European Medicines Agency

13-6-2018

Veraflox (Bayer Animal Health GmbH)

Veraflox (Bayer Animal Health GmbH)

Veraflox (Active substance: Pradofloxacin) - Centralised - Yearly update - Commission Decision (2018)3834 of Wed, 13 Jun 2018

Europe -DG Health and Food Safety

24-5-2018

Regulatory and procedural guideline:  EudraVigilance release notes v.1.14

Regulatory and procedural guideline: EudraVigilance release notes v.1.14

This document lists and briefly describes the following areas for the releases of EVWEB starting with the release on 22 November 2017.

Europe - EMA - European Medicines Agency

23-5-2018

Scientific guideline:  Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

Scientific guideline: Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

The guideline lays down the principles for the two-step release and shipping of the investigational medicinal products by the qualified person and the sponsor. The guideline also describes the areas of interface between the manufacturer and the sponsor and the required contractual agreements.

Europe - EMA - European Medicines Agency