METAGENICS PREGNANCY CARE ADVANCED

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

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Active ingredient:
betacarotene,Biotin,calcium ascorbate dihydrate,calcium pantothenate,choline bitartrate,chromium nicotinate,colecalciferol,folic acid,iron amino acid chelate,levomefolate glucosamine,lutein,manganese amino acid chelate,mecobalamin (co-methylcobalamin),menaquinone 7,molybdenum trioxide,nicotinamide,potassium iodide,pyridoxal 5-phosphate monohydrate,pyridoxine hydrochloride,riboflavin sodium phosphate,selenomethionine,thiamine hydrochloride,zinc amino acid chelate
Available from:
Metagenics (Aust) Pty Ltd
Authorization status:
Listed
Authorization number:
321471

Public Summary

Summary for ARTG Entry:

321471

METAGENICS PREGNANCY CARE ADVANCED

ARTG entry for

Medicine Listed

Sponsor

Metagenics (Aust) Pty Ltd

Postal Address

PO Box 675,VIRGINIA BC, QLD, 4014

Australia

ARTG Start Date

8/08/2019

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. METAGENICS PREGNANCY CARE ADVANCED

Product Type

Single Medicine Product

Effective date

20/08/2019

Permitted Indications

Helps prevent dietary (state vitamin/mineral/nutrient) deficiency in breastfeeding women

Helps prevent dietary (state vitamin/mineral/nutrient) deficiency in breast fed healthy infants

Maintains/support healthy foetal development

Maintain/support healthy pregnancy

Help to prevent neural tube defects such as spina bifida and/or anencephaly

Maintain/support preconception health

Indication Requirements

Label statement: Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester.

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.

Product presentation must not imply or refer to infertility.

Indication can only be used for medicines that contain folic acid as an active ingredient and the recommended daily dose of the medicine provides a

minimum of 400 micrograms of folic acid. Product pre

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

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).

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

Public Summary

Page 1 of

Produced at 29.08.2019 at 05:18:22 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

be exceeded.

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

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

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

Not recorded

Not recorded

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

betacarotene

3 mg

Biotin

35 microgram

calcium ascorbate dihydrate

60.52 mg

calcium pantothenate

12.5 mg

choline bitartrate

167.15 mg

chromium nicotinate

250 microgram

colecalciferol

.0125 mg

folic acid

200 microgram

iron amino acid chelate

60 mg

levomefolate glucosamine

97.05 microgram

lutein

1 mg

manganese amino acid chelate

7.8 mg

mecobalamin (co-methylcobalamin)

250 microgram

menaquinone 7

.015 mg

molybdenum trioxide

37.51 microgram

nicotinamide

15 mg

potassium iodide

195.5 microgram

pyridoxal 5-phosphate monohydrate

12.5 mg

pyridoxine hydrochloride

12.5 mg

riboflavin sodium phosphate

12.5 mg

selenomethionine

62.19 microgram

thiamine hydrochloride

12.5 mg

zinc amino acid chelate

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 29.08.2019 at 05:18:22 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

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