Swisse

Main information

  • Trade name:
  • Swisse Ultiboost Calcium + Vitamin D
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Swisse Ultiboost Calcium + Vitamin D
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218460
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218460

Swisse Ultiboost Calcium + Vitamin D

ARTG entry for

Medicine Listed

Sponsor

Swisse Wellness Pty Ltd

Postal Address

111 Cambridge Street,Collingwood, VIC, 3066

Australia

ARTG Start Date

12/12/2013

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. Swisse Ultiboost Calcium + Vitamin D

Product Type

Single Medicine Product

Effective date

18/07/2017

Warnings

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

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

Standard Indications

Source of calcium. May assist in the prevention and/or treatment of osteoporosis.

Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention

and/or treatment of osteoporosis.

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).

Specific Indications

Aids, assists or helps in the maintenance or improvement of general wellbeing/supports general wellbeing. Source of calcium, nutritional support for a

diet low in calcium. Calcium and vitmain D help maintain/support strong, healthy bones and teeth/supports bone and skeletal strength. Contains vitamin

D3 for increased calcium absorption. Vitamin D promotes the body's absorption of calcium, important/essential to maintain healthy bones and teeth.

Source of calcium. Vitamin D supplementation may assist/support in regulation of calcium metbolism and bone mineralisation/bone mineral density in

those not obtaining sufficient vitamin D due to diet or lifestyle factors. Calcium requirements may be increased with age, gender, diet, pregnancy and

lactation. Women's calcium requirements are increased after/post menopause. A diet deficient in calcium can lead to osteoporosis in later life. The

human skeleton consists of 206 bones that provide a framework for the body to help maintain shape, protect vital organs and provide a place for muscles

and supporting structures to attach. Bones also function as a site for mineral storage and blood formation. Vitamin D helps support healthy bones and

teeth. Contains the bioavailable calcium citrate to help optimise/assist calcium absorption. Formulated with naturally derived vitamin D3. Calcium

contributes to/helps/supports normal/healthy muscle function.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Public Summary

Page 1 of

Produced at 19.10.2017 at 06:03:39 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

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

calcium citrate tetrahydrate

1.5798 g

colecalciferol

.0083 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 19.10.2017 at 06:03:39 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

7-12-2018

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Published on: Thu, 06 Dec 2018 The present scientific opinion deals with the assessment of the bioavailability of magnesium, from the proposed nutrient source, magnesium citrate malate (MgCM), when added for nutritional purposes to food supplements. MgCM is a mixed salt consisting of magnesium cations and citrate and malate anions, and with a magnesium content of 12–15%. MgCM is proposed to be used in food supplements that are intended to provide up to 300–540 mg/day magnesium. The data provided demonst...

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Consultation responses on the future reimbursement status of dihydropyridine calcium antagonists (C08CA)

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The Danish Medicines Agency's assessment of the future reimbursement status of the dihydropyridine calcium antagonists (C08CA) were submitted for consultation with 11 November 2008 as the consultation deadline.

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29-10-2008

Reassessment of reimbursement status for medicinal products in ATC group C08CA

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8-9-2008

Reassessment of reimbursement status of medicinal products for cardiovascular diseases – additional recommendation from the Reimbursement Committee

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The Danish Medicines Agency has asked the Reimbursement Committee to reassess the reimbursement status of medicinal products authorised for marketing in Denmark in the ATC groups C02 (antihypertensives), C03 (diuretics), C07 (beta blocking agents), C08 (calcium channel blockers) and C09 (ACE inhibitors, angiotensin II antagonists and renin inhibitors).

Danish Medicines Agency

14-2-2008

Reassessment of reimbursement status for medicinal products for the treatment of cardiovascular diseases

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Following a request from the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status for medicinal products authorised for marketing in Denmark in ATC groups C02 (antihypertensives), C03 (diuretics), C07 (beta blocking agents), C08 (calcium channel blockers) and C09 (ACE inhibitors, angiotensin II antagonists and renin inhibitors).

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11-3-2019

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Opinion/decision on a Paediatric investigation plan (PIP): arimoclomol citrate, decision type: , therapeutic area: , PIP number: P/0317/2018

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18-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Omega-3-acid ethyl esters 90 / rosuvastatin (calcium), decision type: , therapeutic area: , PIP number: P/0309/2018

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