METAGENICS
Main information
- Trade name:
- METAGENICS VITAMIN D3 LIQUID
- Active ingredient:
- colecalciferol
- Available from:
- Health World Ltd
- INN (International Name):
- colecalciferol
- Medicine domain:
- Humans
- Medicine type:
- Allopathic drug
Documents
- for the general public:
- Public Assessment Report
-
- for the general public:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
- for healthcare professionals:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for healthcare professionals.
Localization
- Available in:
-
Australia
- Language:
- English
Other information
Status
- Source:
- Dept. of Health,Therapeutic Goods Administration - Australia
- Authorization number:
- 217948
- Last update:
- 08-10-2017
Public Assessment Report
Public Summary
Summary for ARTG Entry:
217948
METAGENICS VITAMIN D3 LIQUID
ARTG entry for
Medicine Listed
Sponsor
Health World Ltd
Postal Address
PO Box 675,VIRGINIA BC, QLD, 4014
Australia
ARTG Start Date
2/12/2013
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. METAGENICS VITAMIN D3 LIQUID
Product Type
Single Medicine Product
Effective date
7/10/2016
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
Vitamin D helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life
Aids, assists or helps in the maintenance or improvement of general well-being.
Specific Indications
Maintains normal healthy immune function/immunity.
Supplementation with vitamin D may increase vitamin D levels.
When taken in conjunction with the recommended daily intake of calcium, Vitamin D may help to reduce the risk of falls in the elderly by improving
muscle strength, which may reduce the risk of fractures.
Vitamin D is an essential nutrient for normal healthy bones.
Nutritional support for the maintenance of healthy skeletal, cardiovascular and immune systems.
Vitamin D3 aids in healthy calcium absorption and metabolism.
A significant number of Australians are at risk of vitamin D deficiency due to poor dietary intake and inadequate sun exposure.
Many elderly people, postmenopausal women and those with osteoporosis have low levels of vitamin D.
Concentrated and stabilised for strength and potency.
Glass is impervious to oxygen.
Metagenics in-use stability trials indicate the use of a glass bottle and rubber seal/dropper combination produces a barrier against oxygen to produce a
stable product.
Additional Product information
Pack Size/Poison information
Public Summary
Page 1 of
Produced at 26.11.2017 at 05:45:32 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
Pack Size
Poison Schedule
Components
1. Formulation 1
Dosage Form
Oral Liquid
Route of Administration
Oral
Visual Identification
Active Ingredients
colecalciferol
.1 mg/mL
© 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 26.11.2017 at 05:45:32 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
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
Documents in other languages are available here
- Access to this document is only available to registered users.
Register now for full access
19-7-2018

Human medicines European public assessment report (EPAR): Adrovance, alendronic acid / colecalciferol, Revision: 18, Authorised
Europe - EMA - European Medicines Agency
13-7-2018

Human medicines European public assessment report (EPAR): Vantavo (previously Alendronate sodium and colecalciferol, MSD), alendronic acid / colecalciferol, Revision: 12, Authorised
Europe - EMA - European Medicines Agency
13-7-2018

Human medicines European public assessment report (EPAR): Fosavance, alendronic acid / colecalciferol, Revision: 20, Authorised
Europe - EMA - European Medicines Agency
11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)
Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42
Europe -DG Health and Food Safety
11-7-2018

Vantavo (Merck Sharp and Dohme B.V.)
Vantavo (Active substance: alendronic acid / colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1180/T/30
Europe -DG Health and Food Safety
10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)
Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39
Europe -DG Health and Food Safety