Stayyounglonger.info

Summary for ARTG
ARTG entry for
Postal Address
Unit 9 / 7 Anella Avenue,CASTLE HILL, NSW, 2154 Australia ARTG Start Date
Product type:
Approval area:
Conditions
Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Therapeutic Goods Act 1989, shall be only those included in the list of 'Colourings permitted in medicines for oral use' available at http://www.tga.gov.au/industry/cm-colourings-oral-use.htm,as amended from time to time.
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 Office of Complementary Medicines, 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, Officeof 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 notifiedof 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. Protandim
Product Type
Effective date
Warnings
If symptoms persist consult your healthcare practitioner (or words to that effect).
Contains caffeine [state quantity per dosage unit or per mL or per gram of product] [must be clear and legible].
Standard Indications
Beneficial during times of stress. [Warning S required] Aids, assists or helps in the maintenance or improvement of general well-being.
Help reduce effects of mild anxiety and nervous tension. [Warning S required] Relief of indigestion. [Warning S required] May assist in the management of non-specific dyspepsia. [Warning S required] Liver tonic. Helps maintain healthy digestive function.
Helps maintain healthy digestive function.
Liver tonic. Relief of indigestion. [Warning S required] Specific Indications
Protection against oxidative stress.
Essential for normal metabolism and protects cells against oxidative stress.
Antioxidants help to reduce effects caused by free radical scavengers.
Assists in maintaining peak effort.
Helps body adapt to physically and mentally draining circumstances.
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
Helps maintain normal vitality/energy.
Helps support/maintain healthy immune function.
Relief of stress and mild anxiety.
Supports/maintains the body's normal ability to cope during times of stress.
Helps release the feelings of fatigue caused by stress.
Additional Product information
Container information
Material
Life Time
Temperature
Conditions
Neither child resistant Not recordedclosure nor restricted flow insert Pack Size/Poison information
Pack Size
Poison Schedule
Components
1. Formulation 1
Dosage Form
Route of Administration
Visual Identification
Active Ingredients
Bacopa monnieri
Camellia sinensis
Curcuma longa
Silybum marianum
Withania somnifera
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

Source: http://www.stayyounglonger.info/storage/tgaimages/TGAProtandim.pdf