Ultra

Main information

  • Trade name:
  • Ultra DHA for Pregnancy & Lactation
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Ultra DHA for Pregnancy & Lactation
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218692
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218692

Ultra DHA for Pregnancy & Lactation

ARTG entry for

Medicine Listed

Sponsor

Tasman Pacific Holding Pty Ltd

Postal Address

4 Bridge Street,RYDALMERE, NSW, 2116

Australia

ARTG Start Date

19/12/2013

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. Ultra DHA for Pregnancy & Lactation

Product Type

Single Medicine Product

Effective date

19/12/2013

Warnings

No Warnings included on Record

Standard Indications

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

Specific Indications

* Maintains normal healthy brain function.

* Supports brain health.

* Helps to support cognitive function.

* Maintains normal healthy nervous system.

* Omega 3 fatty acids help to maintain a healthy nervous system.

* Omega-3 essential fatty acids are necessary for healthy nervous system function.

* A natural source of marine omega 3 fatty acids.

* Omega 3 fatty acids are very important as the body cannot produce them and they can therefore only obtain them from the diet.

* Supports healthy eye function.

* Supports the health of the eyes.

* Helps to support the development of the eyes.

* DHA is essential for the growth and development of the brain in both the foetal and neonatal stages.

* Helps support cognitive health and/or brain function. Helps support the development of the brain, eyes and nerves in children up to 12 years of age.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Public Summary

Page 1 of

Produced at 26.11.2017 at 04:33:49 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

Visual Identification

Active Ingredients

concentrated fish Omega-3 triglycerides

700 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 26.11.2017 at 04:33:49 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

8-11-2018

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

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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

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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

4-9-2018

H&C Food Inc. Issues Allergy Alert on Undeclared Wheat, Pork, Egg, and Crustacean in Frozen Fish Balls

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H&C Food Inc of Brooklyn, NY is recalling the Frozen Fuzhou Fish Balls and the Fish Balls, because they may contain undeclared wheat, pork, egg, and crustacean. People who have an allergy or severe sensitivity to wheat, pork, egg and crustacean run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

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FDA - U.S. Food and Drug Administration

24-7-2018

Pepperidge Farm® Announces Voluntary Recall of Four Varieties of Goldfish® Crackers

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Pepperidge Farm has been notified by one of its ingredient suppliers that whey powder in a seasoning that is applied to four varieties of crackers has been the subject of a recall by the whey powder manufacturer due to the potential presence of Salmonella. Pepperidge Farm initiated an investigation and, out of an abundance of caution, is voluntarily recalling four varieties of Goldfish crackers. The products were distributed throughout the United States. No illnesses have been reported. ...

FDA - U.S. Food and Drug Administration

24-7-2018

Statement from FDA Commissioner Scott Gottlieb, M.D. on voluntary recalls of Ritz, Goldfish and other products issued out of an abundance of caution

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The U.S. Food and Drug Administration is working with Mondelēz International, Inc., Pepperidge Farm Inc. and Flowers Foods, Inc. to initiate voluntarily recalls of certain products due to a potential risk that one of the ingredients may have been contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

28-6-2018

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France - Agence Nationale du Médicament Vétérinaire

14-6-2018

ANSES consolidates its presence in Boulogne-sur-Mer!

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France - Agence Nationale du Médicament Vétérinaire

13-6-2018

World Variety Produce, Inc. Voluntarily Recalls Spicy Edamame Because Of Undeclared Allergens

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FDA - U.S. Food and Drug Administration

5-6-2018

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

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FDA - U.S. Food and Drug Administration

29-5-2018

Orphan designation:  Pasireotide,  for the: Treatment of acromegaly

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Europe - EMA - European Medicines Agency

12-4-2018

Cookwell & Company Issues Allergy Alert for Undeclared Soy, Wheat and Fish Allergen in Charred Tomato & Basil Sauce with a “Best By” Date of “10 Nov 18”

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FDA - U.S. Food and Drug Administration

16-11-2017

Medicines Safety Update, Volume 8, Number 5, October-November 2017

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Therapeutic Goods Administration - Australia

22-10-2018

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

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Europe -DG Health and Food Safety

21-10-2018

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding  ht

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Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding https://go.usa.gov/xPnda . pic.twitter.com/nktV9BDAC3

FDA - U.S. Food and Drug Administration

7-9-2018

 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

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Europe - EMA - European Medicines Agency

27-8-2018

Mepsevii (Ultragenyx Germany GmbH)

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Europe -DG Health and Food Safety

25-5-2018

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Skin cancer is the most preventable type of cancer. Avoiding sunburn and overexposure to the sun's ultraviolet rays is key: https://survivorship.cancer.gov/springboard/wellness/sun-safety … #dontfrydaypic.twitter.com/1vzXm28tQC

Skin cancer is the most preventable type of cancer. Avoiding sunburn and overexposure to the sun's ultraviolet rays is key: https://survivorship.cancer.gov/springboard/wellness/sun-safety … #dontfryday pic.twitter.com/1vzXm28tQC

FDA - U.S. Food and Drug Administration

18-4-2018

EU/3/18/2011 (Ultragenyx Germany GmbH)

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Europe -DG Health and Food Safety