Cenovis Men's Multi + Performance

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Active ingredient:
ascorbic acid,betacarotene,boric acid,Biotin,calcium carbonate,calcium pantothenate,chromium picolinate,colecalciferol,cupric sulfate,cyanocobalamin,Citrus bioflavonoids extract,d-alpha-tocopherol,ferrous fumarate,folic acid,heavy magnesium oxide,manganese sulfate monohydrate,nicotinamide,phytomenadione,potassium iodide,pyridoxine hydrochloride,Panax ginseng,riboflavine,selenomethionine,thiamine nitrate,zinc oxide
Available from:
Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare
Authorization status:
Listed
Authorization number:
322406

Public Summary

Summary for ARTG Entry:

322406

Cenovis Men's Multi + Performance

ARTG entry for

Medicine Listed

Sponsor

Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare

Postal Address

PO Box 403,VIRGINIA, QLD, 4014

Australia

ARTG Start Date

28/08/2019

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. Cenovis Men's Multi + Performance

Product Type

Single Medicine Product

Effective date

28/08/2019

Permitted Indications

Maintain/support energy levels

Maintain/support energy production

Maintain/support physical endurance/capacity/stamina

Relieve weariness/tiredness/fatigue/feeling of weakness

Maintain/support general health and wellbeing

Maintain/support healthy immune system function

Maintain/support (state vitamin/mineral) within normal range

Maintain/support cognitive function/mental function

Maintain/support nervous system function

Maintain/support reproductive system health in males

Indication Requirements

Product presentation must not imply or refer to imply chronic fatigue syndrome.

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to infertility.

Product presentation must not imply or refer to serious immunological diseases.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased

physical activity.

Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not

replace a balanced diet.

Public Summary

Page 1 of

Produced at 29.08.2019 at 03:58:30 AEST

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

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

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

This product contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not

be exceeded.

Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not replace a balanced

diet.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

ascorbic acid

100 mg

betacarotene

1.2 mg

Biotin

150 microgram

boric acid

5.72 mg

calcium carbonate

200 mg

calcium pantothenate

30 mg

chromium picolinate

285 microgram

Citrus bioflavonoids extract

2 mg

colecalciferol

10 microgram

cupric sulfate

2.51 mg

cyanocobalamin

25 microgram

d-alpha-tocopherol

30 mg

ferrous fumarate

15.21 mg

folic acid

300 microgram

heavy magnesium oxide

85.91 mg

manganese sulfate monohydrate

3.08 mg

nicotinamide

50 mg

Panax ginseng

120 mg

Equivalent: Panax ginseng (Dry)

600 mg

phytomenadione

40 microgram

potassium iodide

196 microgram

pyridoxine hydrochloride

15 mg

riboflavine

15 mg

selenomethionine

250 microgram

thiamine nitrate

15 mg

zinc oxide

18.67 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 29.08.2019 at 03:58:31 AEST

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

Similar products

Search alerts related to this product

Share this information