Oviit

Main information

  • Trade name:
  • Oviit Vision Plus
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Oviit Vision Plus
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219598
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219598

Oviit Vision Plus

ARTG entry for

Medicine Listed

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

24/01/2014

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. Oviit Vision Plus

Product Type

Single Medicine Product

Effective date

16/10/2017

Warnings

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

WARNING: May be dangerous if taken in large amounts or for a long period. OR WARNING: Contains zinc which may be dangerous if taken in large

amounts or for a long period (or words to that effect).

Standard Indications

Eyes formula. Support of healthy eye function.

Maintenance of healthy eyes.

Specific Indications

May help maintain eye health.

Provides nutrients important to the macular region of the eye.

Antioxidants help control free radical damage in the macular region of the eye.

Vision formula

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:44:40 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

Ascorbic acid

250 mg

Copper gluconate

7.14 mg

d-alpha-Tocopherol

134.2 mg

zinc oxide

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 23.11.2017 at 12:44:40 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

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

6-7-2017

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

On 26 June 2017, the European Commission adopted a decision to withdraw all marketing authorisations for veterinary medicinal products containing zinc oxide administered orally to food producing species. The medicinal products affected by the decision appear from Annex I to the decision.

Danish Medicines Agency

21-3-2017

New recommendation for phasing out zinc oxide for young pigs

New recommendation for phasing out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has confirmed a previous decision to phase out zinc oxide. Consequently, the CVMP has once more recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

5-1-2017

Re-examination of the CVMP's decision to phase out zinc oxide for young pigs

Re-examination of the CVMP's decision to phase out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) will re-examine the decision to phase out medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs.

Danish Medicines Agency

19-12-2016

Zinc oxide for young pigs to be phased out

Zinc oxide for young pigs to be phased out

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

12-6-2018

EU/3/17/1955 (Sangamo Therapeutics UK LTD)

EU/3/17/1955 (Sangamo Therapeutics UK LTD)

EU/3/17/1955 (Active substance: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human alpha L-iduronidase gene) - Transfer of orphan designation - Commission Decision (2018)3810 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/167/17/T/01

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Active substance: Adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene) - Orphan designation - Commission Decision (2018)2403 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/255/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2000 (Amicus Therapeutics UK Ltd)

EU/3/18/2000 (Amicus Therapeutics UK Ltd)

EU/3/18/2000 (Active substance: Recombinant human acid alpha-glucosidase) - Orphan designation - Commission Decision (2018)1877 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/230/17

Europe -DG Health and Food Safety