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

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

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Several children's strawberry-flavoured acetaminophen syrups recalled because of defective child-resistant safety caps on the bottles

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Health Canada

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Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

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Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

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Health Canada

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Pest categorisation of Conotrachelus nenuphar

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30-10-2018

Pest categorisation of Sternochetus mangiferae

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Pest categorisation of Aleurocanthus spp.

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19-10-2018

Hy-Vee Voluntarily Recalls Several Meat and Potato Products

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Pest categorisation of Melampsora farlowii

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Europe - EFSA - European Food Safety Authority Publications

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Europe - EFSA - European Food Safety Authority Publications

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Europe - EFSA - European Food Safety Authority Publications

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11-9-2018

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Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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1-9-2018

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Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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27-8-2018

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Apricot kernels pose a risk of cyanide poisoning

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FDA - U.S. Food and Drug Administration

17-7-2018

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13-7-2018

FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

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FDA - U.S. Food and Drug Administration

9-7-2018

Several drugs containing valsartan being recalled due to contamination with a potential carcinogen

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Health Canada

25-6-2018

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Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

22-6-2018

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Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

21-6-2018

Staatssecretaris Blokhuis naar Caribisch gebied over zorg en preventie

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Staatssecretaris Paul Blokhuis (VWS) bezoekt vanaf donderdag 21 juni tot en met woensdag 27 juni 2018 een serie zorginstellingen op de bovenwindse eilanden Saba en Sint Eustatius. Alle gezondheidszorg, ouderenzorg en jeugdzorg in Caribisch Nederland vallen onder de verantwoordelijkheid van de staatssecretaris van VWS.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

6-6-2018

Philippe Reignault appointed Director of the Plant Health Laboratory and Director of Plant Health at ANSES

Philippe Reignault appointed Director of the Plant Health Laboratory and Director of Plant Health at ANSES

On 4 June, Philippe Reignault was appointed Director of the ANSES Plant Health Laboratory and will also take over from Charles Manceau as Director of Plant Health, with effect from July. Professor of Plant Biology and Diseases at the Littoral Côte d'Opale University since 2010 and Chair of ANSES's Expert Committee on Plant Health since 2012, he will now be responsible for overall coordination of ANSES's scientific work in plant health and protection.

France - Agence Nationale du Médicament Vétérinaire

28-5-2018

Health Canada warns of safety hazards with several uncertified USB chargers

Health Canada warns of safety hazards with several uncertified USB chargers

As part of a planned national sampling and compliance project, Health Canada tested a number of uncertified USB chargers. The following products were found to pose an unacceptable risk of electric shock and fire and are being recalled. This table will be updated if and when new products are recalled.

Health Canada

4-5-2018

Unauthorized "Sāj" kratom products seized from two Edmonton stores may pose serious health risks

Unauthorized "Sāj" kratom products seized from two Edmonton stores may pose serious health risks

Health Canada is advising Canadians that several “Sāj” brand kratom products were seized from two Edmonton stores (Sāj, located at Sherbrooke Plaza, 11839 St Albert Trail, and Jupiter, located on 12841 97th Street NW). Kratom products are not authorized by Health Canada and may pose serious health risks.

Health Canada

16-3-2018

"Beyond Yourself Multi Athlete" and unauthorized bulk "Multi-Vitamines" seized from Shop Santé stores in Quebec may pose serious health risks

"Beyond Yourself Multi Athlete" and unauthorized bulk "Multi-Vitamines" seized from Shop Santé stores in Quebec may pose serious health risks

Health Canada is advising Canadians that "Beyond Yourself Multi Athlete" multivitamin and unauthorized "Multi-Vitamines" sold in bulk were seized from several Shop Santé stores in Quebec because they may pose serious health risks.

Health Canada

27-7-2017

Counterfeit packs of the schizophrenia medicine Xeplion 150 mg

Counterfeit packs of the schizophrenia medicine Xeplion 150 mg

One German and several Danish parallel importers and the Danish Medicines Agency have withdrawn several batches of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batches contained counterfeit packs.

Danish Medicines Agency

9-7-2013

Voluntary Harmonisation Procedure (VHP) for the assessment of multinational clinical trial applications

Voluntary Harmonisation Procedure (VHP) for the assessment of multinational clinical trial applications

The Voluntary Harmonisation Procedure is a procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries.

Danish Medicines Agency

18-12-2006

Consultation on recommended changes of the reimbursement status of lipid-lowering medicinal products

Consultation on recommended changes of the reimbursement status of lipid-lowering medicinal products

At several meetings, the Reimbursement Committee has discussed the reimbursement status of lipid-lowering medicinal products. In its recommendation of 7 September 2006 for the Danish Medicines Agency, the Committee suggests a change of reimbursement status for these medicinal products.

Danish Medicines Agency

7-9-2018

 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research netw...

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