Elevit Film Coated Tablet

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

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Active ingredient:
ascorbic acid,Biotin,calcium hydrogen phosphate,calcium pantothenate,cyanocobalamin,Cholecalciferol,Cupric sulfate anhydrous,dl-alpha-tocopheryl acetate,ferrous fumarate,folic acid,heavy magnesium oxide,manganese sulfate monohydrate,nicotinamide,potassium iodide,pyridoxine hydrochloride,riboflavine,sodium selenite,thiamine nitrate,zinc citrate trihydrate
Available from:
Bayer Australia Ltd
INN (International Name):
Ascorbic acid,Biotin,calcium hydrogen phosphate,Calcium pantothenate,Cholecalciferol,Cupric sulfate anhydrous,Cyanocobalamin,dl-
Authorization status:
Registered
Authorization number:
291221

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Public Summary

Summary for ARTG Entry:

291221

Elevit Film Coated Tablet

ARTG entry for

Medicine Registered

Sponsor

Bayer Australia Ltd

Postal Address

PO Box 182,Gordon NSW 2072,Gordon, NSW, 2072

Australia

ARTG Start Date

7/07/2017

Product category

Medicine

Status

Active

Approval area

Office of Complementary Medicine

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. Elevit Film Coated Tablet

Product Type

Single Medicine Product

Effective date

7/07/2017

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For assistance in the prevention and treatment of dietary iron and folate deficiency.,For prevention of dietary vitamin and mineral deficiencies due to

increased needs during pregnancy and lactation.,Folic acid taken at least one month prior to and during pregnancy may reduce the risk of neural tube

defects such as 'spina bifida'.,Iron to help prevent iron deficiency.,Iodine to assist the development of baby's brain.,To help meet the increased needs of

the mother-to-be and to help provide her growing baby with nutritional support throughout its whole development - from conception, through pregnancy

and on to breast-feeding.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S2) Pharmacy Medicine

(S2) Pharmacy Medicine

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to slightly yellowish oval and biconvex film-coated tablet

Active Ingredients

Ascorbic acid

85 mg

Biotin

30 microgram

calcium hydrogen phosphate

407.67 mg

Calcium pantothenate

6.518 mg

Cholecalciferol

.025 mg

Cupric sulfate anhydrous

2.51 mg

Cyanocobalamin

.0026 mg

dl-alpha-Tocopheryl acetate

20.5 mg

Ferrous fumarate

182.52 mg

Folic acid

800 microgram

Public Summary

Page 1 of

Produced at 24.11.2017 at 08:15:05 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

heavy magnesium oxide

165.25 mg

Manganese sulfate monohydrate

5.7 mg

Nicotinamide

18 mg

potassium iodide

288 microgram

pyridoxine hydrochloride

2.2644 mg

riboflavine

1.4 mg

sodium selenite

.1045 mg

Thiamine nitrate

1.6983 mg

zinc citrate trihydrate

35.24 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 24.11.2017 at 08:15:05 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

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