Cellulitex

Main information

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

Documents

Localization

  • Available in:
  • Cellulitex
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216766
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216766

Cellulitex

ARTG entry for

Medicine Listed

Sponsor

Divinita International Pty Ltd

Postal Address

159 Bridgeman Road,BRIDGEMAN DOWNS, QLD, 4035

Australia

ARTG Start Date

31/10/2013

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. Cellulitex

Product Type

Single Medicine Product

Effective date

31/10/2013

Warnings

Drink plenty of water (or words to that effect).

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

Standard Indications

For the symptomatic relief of non-specific dyspepsia. [Warning S required]

May assist in the management of non-specific dyspepsia. [Warning S required]

Aids or assists in the relief of constipation. [Warnings S and LAX1 required / LAX2 required in certain circumstances]

For the symptomatic relief of constipation. [Warnings S and LAX1 required / LAX2 required in certain circumstances]

Liver tonic. Aids digestion.

Helps maintain healthy digestive function.

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

Aids or assists in the relief of flatulence. [Warning S required]

Liver tonic. Aids or assists in the relief of flatulence. [Warning S required]

Aids digestion.

Specific Indications

* Iodine is an essential nutrient required for normal thyroid function.

* Iodine is important for the normal functioning of the thyroid gland as it is an essential nutrient required for the synthesis of thyroid hormones.

* Thyroid hormones have a direct effect on energy expenditure.

* Ascophyllum nodosum has demonstrated antioxidant effect.

* Free radical scavenger.

* Contains antioxidant ingredients and therefore assists in protecting the cells of the body from free radical damage.

* Helps protects cells from free radical damage.

* Factors such as stress, alcohol, cigarettes and pollution may increase free radicals in the body and the potential for oxidative damage.

* Antioxidants are involved in inhibiting cellular damage attributed to free radicals.

* Antioxidants protect the body from the damaging effects of free radicals.

* Antioxidants reduce the risk of cell damage attributed to free radicals.

Public Summary

Page 1 of

Produced at 26.11.2017 at 07:15:42 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

* Ascophyllum is a source of iodine.

* Globe artichoke and dandelion root have been traditionally used in herbal medicine as choleretic and diuretic herbs to support and support/maintain

liver function.

* Maintains normal liver & gall bladder function.

* Assists liver detoxification processes.

* Supports healthy liver function.

* May assist in the relief of symptoms of nausea, vomiting, abdominal pain and loss of appetite.

* May assist in maintaining normal (and/or healthy) cholesterol levels in healthy people.

* May help to maintain cholesterol levels within the normal (and or healthy) range in healthy people and improve HDL:LDL ratio.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Ascophyllum nodosum

190 mg

Cynara scolymus

133.33 mg

Equivalent: Cynara scolymus (Dry)

Taraxacum officinale

125 mg

Equivalent: Taraxacum officinale (Dry)

500 mg

© 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 07:15:42 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