Oviit

Main information

Documents

Localization

  • Available in:
  • Oviit Vitamin B Complex
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220410
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220410

Oviit Vitamin B Complex

ARTG entry for

Medicine Listed

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

24/02/2014

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. Oviit Vitamin B Complex

Product Type

Single Medicine Product

Effective date

17/03/2017

Warnings

WARNING - this medication may be dangerous when used in large amounts or for a long time; or WARNING - this product contains [insert pyridoxine

hydrochloride or pyridoxal 5-phosphate as applicable], which may be dangerous when used in large amounts or for a long time.

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

Do not exceed the stated dose except on medical advice. If you have had a baby with a neural tube defect/spina bifida, seek specific medical advice (or

words to that effect).

Standard Indications

Source of folic acid. Can assist in maintaining normal blood. Blood tonic.

Source of folic acid. Can assist in maintaining normal blood.

May assist in the management of dietary vitamin B12 deficiency.

Prevention/treatment of vitamin [XX] and/or mineral [YY] and/or nutritional deficiencies (This indication is not be to used for the treatment of iron

deficiency conditions).

Source of vitamin B12. Can assist in maintaining normal blood. Blood tonic.

Source of vitamin B12. Can assist in maintaining normal blood.

Helps maintain normal blood/blood tonic (Note: These claims are appropriate for folic acid, vitamin B12 and iron, but must not imply anaemic conditions)

Provides a daily dose of 400-500mcg of folic acid or folate. Contains folic acid which, if taken daily for one month before conception and during

pregnancy, may reduce the risk of women having a child with birth defects of the brain and/or spinal chord such as the neural tube defects known as

spina bifida and anencephaly. [Warning NEUR required.]

Provides a daily dose of 400-500mcg of folic acid or folate. Contains folic acid which, if taken daily for one month before conception and during

pregnancy, may reduce the risk of having a child with spina bifida/neural tube defects. [Warning NEUR required].

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

For vitamin (may state the vitamin) supplementation.

Specific Indications

Vitamin B Complex facilitates energy production in the body.

Thiamine nitrate (Vitamin B1), riboflavine (Vitamin B2), pyridoxine (Vitamin B6) and cyanocobalamin (Vitamin B12) help the body to metabolize

Public Summary

Page 1 of

Produced at 22.11.2017 at 11:30:29 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

carbohydrates, fats and proteins.

Thiamine nitrate (Vitamin B1) helps normal growth.

Riboflavine (Vitamin B2) is a factor in the maintenance of good health.

Riboflavine (Vitamin B2) and pyridoxine hydrochloride (Vitamin B6) helps with tissue formation.

Riboflavine (vitamin B2) is essential for the utilisation of energy from food.

Pyridoxine (Vitamin B6) is a factor in the maintenance of good health.

Pyridoxine (Vitamin B6) is required for the formation of haemoglobin.

Cyanocobalamin (Vitamin B12) helps to form red blood cells.

Cyanocobalamin (Vitamin B12) is essential for the normal function of all cells.

Nicotinamide is involved in a wide range of biological functions such as energy production and fatty acid synthesis.

Nicotinamide is a strong antioxidant and free radical scavenger.

Daily intake of B vitamins in important as they are not stored in the body.

Folate is involved in a number of important biochemical pathways required for health and wellbeing, in particular development and cell growth.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Ascorbic acid

50 mg

Biotin

50 microgram

Calcium pantothenate

50 mg

Choline bitartrate

50 mg

Cyanocobalamin

.05 mg

Folic acid

400 microgram

Inositol

50 mg

Nicotinamide

50 mg

pyridoxine hydrochloride

50 mg

Riboflavin

50 mg

Thiamine nitrate

50 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 22.11.2017 at 11:30:29 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