Health

Main information

  • Trade name:
  • Health Essence Glucosamine + MSM 1800mg
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Health Essence Glucosamine + MSM 1800mg
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220966
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220966

Health Essence Glucosamine + MSM 1800mg

ARTG entry for

Medicine Listed

Sponsor

Aussia Pharma

Postal Address

PO Box 87,EASTWOOD, NSW, 2122

Australia

ARTG Start Date

11/03/2014

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. Health Essence Glucosamine + MSM 1800mg

Product Type

Single Medicine Product

Effective date

11/03/2014

Warnings

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

Standard Indications

May help reduce joint inflammation associated with arthritis.

May help reduce joint swelling associated with arthritis.

May help increase joint mobility associated with arthritis.

Temporary relief of the pain of osteoarthritis (or) Temporary relief of osteoarthritic pain. [Warning S required]

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

May assist in the management of osteoarthritic pain. [Warning S required]

Symptomatic relief of osteoarthritis. [Warning S required]

May assist in the management of osteoarthritis. [Warning S required]

Temporary relief of the pain of arthritis. (or) Temporary relief of arthritic pain. [Warning S required]

Specific Indications

* Glucosamine is produced naturally in the body and is an important/vital component of cartilage.

* Glucosamine assists in building and maintaining healthy cartilage, which is essential for healthy function of the joints.

* Glucosamine plays a role in the body in the formation of the articular cartilage, tendons, ligaments, synovial fluid & bone.

* Glucosamine is necessary in the body for the structure and function of the articular cartilage.

* Helps maintain healthy joint function and provides structural support to the joints.

* Glucosamine is a naturally occurring compound that helps maintain healthy cartilage.

* Assists in maintaining joint flexibility and function.

* Helps to maintain healthy joint cartilage.

* Helps to maintain the health of the joints.

* Supports/maintains healthy joints.

Additional Product information

Public Summary

Page 1 of

Produced at 26.11.2017 at 01:48:43 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 information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

Active Ingredients

Dimethyl sulfone

300 mg

Glucosamine hydrochloride

1.5 g

© 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 01:48:43 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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15-3-2019

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FDA - U.S. Food and Drug Administration

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13-3-2019

INOmax (Linde Healthcare AB)

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8-3-2019

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FDA - U.S. Food and Drug Administration

8-3-2019

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FDA - U.S. Food and Drug Administration

8-3-2019

EU/3/16/1738 (F2G Biotech GmbH)

EU/3/16/1738 (F2G Biotech GmbH)

EU/3/16/1738 (Active substance: 2-(1,5-dimethyl-3-phenyl-1H-pyrrol-2-yl)-N-{4-[4-(5-fluoro-pyrimidin-2-yl)piperazin-1-yl]-phenyl}-2-oxo-acetamide) - Transfer of orphan designation - Commission Decision (2019)1946 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004537

Europe -DG Health and Food Safety

8-3-2019

EU/3/16/1713 (F2G Biotech GmbH)

EU/3/16/1713 (F2G Biotech GmbH)

EU/3/16/1713 (Active substance: 2-(1,5-dimethyl-3-phenyl-1H-pyrrol-2-yl)-N-{4-[4-(5-fluoro-pyrimidin-2-yl)piperazin-1-yl]-phenyl}-2-oxo-acetamide) - Transfer of orphan designation - Commission Decision (2019)1945 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004529

Europe -DG Health and Food Safety

7-3-2019

DaTSCAN (GE Healthcare B.V.)

DaTSCAN (GE Healthcare B.V.)

DaTSCAN (Active substance: Ioflupane (123I)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1908 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/266/T/57

Europe -DG Health and Food Safety

7-3-2019

Granpidam (Accord Healthcare S.L.U.)

Granpidam (Accord Healthcare S.L.U.)

Granpidam (Active substance: sildenafil) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1914 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4289/T/02

Europe -DG Health and Food Safety

7-3-2019

Pregabalin Accord (Accord Healthcare S.L.U.)

Pregabalin Accord (Accord Healthcare S.L.U.)

Pregabalin Accord (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1913 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4024/T/10

Europe -DG Health and Food Safety

7-3-2019

Aripiprazole Accord (Accord Healthcare S.L.U.)

Aripiprazole Accord (Accord Healthcare S.L.U.)

Aripiprazole Accord (Active substance: aripiprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1915 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4021/T/13

Europe -DG Health and Food Safety

7-3-2019


Orphan designation: Ivacaftor, N-(1,3-dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide, tezacaftor, Treatment of cystic fibrosis, , Positive

Orphan designation: Ivacaftor, N-(1,3-dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide, tezacaftor, Treatment of cystic fibrosis, , Positive

Orphan designation: Ivacaftor, N-(1,3-dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide, tezacaftor, Treatment of cystic fibrosis, , Positive

Europe - EMA - European Medicines Agency

6-3-2019

Fortekor and associated names

Fortekor and associated names

Fortekor and associated names (Active substance: Benazepril hydrochloride) - Corrigendum - Commission Decision (2012)772 of Wed, 06 Mar 2019

Europe -DG Health and Food Safety

5-3-2019

If you get sick with #flu, make sure to take steps for a quick, healthy recovery. 

Stay home and rest, and avoid close contact with others except if you need medical care. Learn more about how to #fightflu this season.  https://bit.ly/2m6lwaM pic.twitter

If you get sick with #flu, make sure to take steps for a quick, healthy recovery. Stay home and rest, and avoid close contact with others except if you need medical care. Learn more about how to #fightflu this season. https://bit.ly/2m6lwaM pic.twitter

If you get sick with #flu, make sure to take steps for a quick, healthy recovery. Stay home and rest, and avoid close contact with others except if you need medical care. Learn more about how to #fightflu this season. https://bit.ly/2m6lwaM  pic.twitter.com/OnpBJLgajA

FDA - U.S. Food and Drug Administration

5-3-2019

Palonosetron Accord (Accord Healthcare S.L.U.)

Palonosetron Accord (Accord Healthcare S.L.U.)

Palonosetron Accord (Active substance: palonosetron) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1825 of Tue, 05 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4129/T/04

Europe -DG Health and Food Safety

5-3-2019

Docetaxel Accord (Accord Healthcare S.L.U.)

Docetaxel Accord (Accord Healthcare S.L.U.)

Docetaxel Accord (Active substance: Docetaxel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1829 of Tue, 05 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2539/T/41

Europe -DG Health and Food Safety

5-3-2019

Lacosamide Accord (Accord Healthcare S.L.U.)

Lacosamide Accord (Accord Healthcare S.L.U.)

Lacosamide Accord (Active substance: lacosamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1831 of Tue, 05 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4443/T/02

Europe -DG Health and Food Safety

5-3-2019

Herzuma (Celltrion Healthcare Hungary Kft.)

Herzuma (Celltrion Healthcare Hungary Kft.)

Herzuma (Active substance: trastuzumab) - Centralised - Yearly update - Commission Decision (2019)1830 of Tue, 05 Mar 2019

Europe -DG Health and Food Safety

5-3-2019

Levetiracetam Accord (Accord Healthcare S.L.U.)

Levetiracetam Accord (Accord Healthcare S.L.U.)

Levetiracetam Accord (Active substance: levetiracetam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1828 of Tue, 05 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2290/T/22

Europe -DG Health and Food Safety

5-3-2019

Lenalidomide Accord (Accord Healthcare S.L.U.)

Lenalidomide Accord (Accord Healthcare S.L.U.)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1827 of Tue, 05 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857/T/01

Europe -DG Health and Food Safety

4-3-2019

Packing contact lenses for your #SpringBreak adventure? Bring your contact lens supplies to help keep your eyes healthy.  https://go.usa.gov/xEgaz pic.twitter.com/TcuoRiFyCT

Packing contact lenses for your #SpringBreak adventure? Bring your contact lens supplies to help keep your eyes healthy. https://go.usa.gov/xEgaz pic.twitter.com/TcuoRiFyCT

Packing contact lenses for your #SpringBreak adventure? Bring your contact lens supplies to help keep your eyes healthy. https://go.usa.gov/xEgaz  pic.twitter.com/TcuoRiFyCT

FDA - U.S. Food and Drug Administration

4-3-2019

Going on a trip this #springbreak? Protect your eyes. Pack extra contact lens supplies in your #travel health kit just in case you need them.  https://bit.ly/2H7gX8X pic.twitter.com/u0KQl03Pax

Going on a trip this #springbreak? Protect your eyes. Pack extra contact lens supplies in your #travel health kit just in case you need them. https://bit.ly/2H7gX8X pic.twitter.com/u0KQl03Pax

Going on a trip this #springbreak? Protect your eyes. Pack extra contact lens supplies in your #travel health kit just in case you need them. https://bit.ly/2H7gX8X  pic.twitter.com/u0KQl03Pax

FDA - U.S. Food and Drug Administration

4-3-2019

EU/3/19/2144 (Accelsiors CRO And Consultancy Services Ltd.)

EU/3/19/2144 (Accelsiors CRO And Consultancy Services Ltd.)

EU/3/19/2144 (Active substance: Poly(N-acetyl, N-arginyl)glucosamine) - Orphan designation - Commission Decision (2019)1736 of Mon, 04 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002552

Europe -DG Health and Food Safety

28-2-2019

EU/3/19/2138 (Common Services Agency (National Health Services - Scotland))

EU/3/19/2138 (Common Services Agency (National Health Services - Scotland))

EU/3/19/2138 (Active substance: Anti-Epstein Barr virus cytotoxic lymphocytes) - Orphan designation - Commission Decision (2019)1730 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002426

Europe -DG Health and Food Safety

27-2-2019

Bortezomib Accord (Accord Healthcare S.L.U.)

Bortezomib Accord (Accord Healthcare S.L.U.)

Bortezomib Accord (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1676 of Wed, 27 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3984/T/17

Europe -DG Health and Food Safety

27-2-2019

Temozolomide Accord (Accord Healthcare S.L.U.)

Temozolomide Accord (Accord Healthcare S.L.U.)

Temozolomide Accord (Active substance: temozolomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1681 of Wed, 27 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/001125/T/0045

Europe -DG Health and Food Safety

27-2-2019

Capecitabine Accord (Accord Healthcare S.L.U.)

Capecitabine Accord (Accord Healthcare S.L.U.)

Capecitabine Accord (Active substance: capecitabine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1682 of Wed, 27 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002386/T/0030

Europe -DG Health and Food Safety

27-2-2019

Entecavir Accord (Accord Healthcare S.L.U.)

Entecavir Accord (Accord Healthcare S.L.U.)

Entecavir Accord (Active substance: entecavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1684 of Wed, 27 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004458/T/0004

Europe -DG Health and Food Safety