CAL-500

Main information

  • Trade name:
  • CAL-500 calcium carbonate 1250mg tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CAL-500 calcium carbonate 1250mg tablets
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 208475
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

208475

CAL-500 calcium carbonate 1250mg tablets

ARTG entry for

Medicine Listed

Sponsor

Petrus Pharmaceuticals Pty Ltd

Postal Address

PO Box 1808,WEST PERTH, WA, 6872

Australia

ARTG Start Date

19/04/2013

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. CAL-500 calcium carbonate 1250mg tablets

Product Type

Single Medicine Product

Effective date

22/05/2015

Warnings

Phenylketonurics are warned that this product contains phenylalanine (or words to that effect).

Contains aspartame.

Standard Indications

Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone.

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.

Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium

supplement formulated to strengthen bone and tissue for children and older adults.

Source of calcium. Women's calcium requirements are increased after menopause.

Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.

Specific Indications

Assists in maintaining healthy bones.Assists in decreasing bone breakdown.Assists in stabilising bone mass.May reduce the risk of osteoporosis.

As an aid in the management of hyperphosphataemia associated with chronic renal failure, hypocalcaemia, proven calcium malabsorption &

osteoporosis

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, chewable

Public Summary

Page 1 of

Produced at 27.11.2017 at 11:06:33 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

Route of Administration

Oral

Visual Identification

Active Ingredients

Calcium carbonate

1.25 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 27.11.2017 at 11:06:33 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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FDA - U.S. Food and Drug Administration

15-3-2019

Today @US_FDA issued an update to a letter to health care providers regarding the potential for increased long-term mortality after use of paclitaxel-coated balloons & paclitaxel-eluting stents to treat peripheral arterial disease:  https://go.usa.gov/xE6

Today @US_FDA issued an update to a letter to health care providers regarding the potential for increased long-term mortality after use of paclitaxel-coated balloons & paclitaxel-eluting stents to treat peripheral arterial disease: https://go.usa.gov/xE6

Today @US_FDA issued an update to a letter to health care providers regarding the potential for increased long-term mortality after use of paclitaxel-coated balloons & paclitaxel-eluting stents to treat peripheral arterial disease: https://go.usa.gov/xE6Wx  #MedicalDevice #FDA pic.twitter.com/ywPS48OwEV

FDA - U.S. Food and Drug Administration

14-3-2019

Follow the #FDA and @CDCgov to stay informed on contact lens safety  https://go.usa.gov/xEHZD  #MedicalDevicepic.twitter.com/gYibolsVzN

Follow the #FDA and @CDCgov to stay informed on contact lens safety https://go.usa.gov/xEHZD  #MedicalDevicepic.twitter.com/gYibolsVzN

Follow the #FDA and @CDCgov to stay informed on contact lens safety https://go.usa.gov/xEHZD  #MedicalDevice pic.twitter.com/gYibolsVzN

FDA - U.S. Food and Drug Administration

11-3-2019

EU/3/14/1337 (ESPL Regulatory Consulting Limited)

EU/3/14/1337 (ESPL Regulatory Consulting Limited)

EU/3/14/1337 (Active substance: Acamprosate calcium) - Transfer of orphan designation - Commission Decision (2019)1944 of Mon, 11 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004283

Europe -DG Health and Food Safety

8-3-2019

Today, the @US_FDA issued a Letter to Healthcare Providers about the increasing number of adverse events associated with surgical staplers for internal use. Read more about the #FDA's recommendations:  https://go.usa.gov/xEGS5  #MedicalDevicepic.twitter.c

Today, the @US_FDA issued a Letter to Healthcare Providers about the increasing number of adverse events associated with surgical staplers for internal use. Read more about the #FDA's recommendations: https://go.usa.gov/xEGS5  #MedicalDevicepic.twitter.c

Today, the @US_FDA issued a Letter to Healthcare Providers about the increasing number of adverse events associated with surgical staplers for internal use. Read more about the #FDA's recommendations: https://go.usa.gov/xEGS5  #MedicalDevice pic.twitter.com/WkmB2yKqUz

FDA - U.S. Food and Drug Administration

8-3-2019

“#DYK Contact lenses are #MedicalDevices? #SpringIntoAction and Check out the @US_FDA’s 7 tips for using contact lenses safely:  https://www.youtube.com/watch?v=ULEuOEEs0AE&feature=youtu.be … …” #FDA #MedicalDevice

“#DYK Contact lenses are #MedicalDevices? #SpringIntoAction and Check out the @US_FDA’s 7 tips for using contact lenses safely: https://www.youtube.com/watch?v=ULEuOEEs0AE&feature=youtu.be … …” #FDA #MedicalDevice

“ #DYK Contact lenses are #MedicalDevices? #SpringIntoAction and Check out the @US_FDA’s 7 tips for using contact lenses safely: https://www.youtube.com/watch?v=ULEuOEEs0AE&feature=youtu.be … …” #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

6-3-2019

Today @US_FDA made an update to a Safety Communication on the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure. Read more:  https://go.usa.gov/xEfkX  #MedicalDev

Today @US_FDA made an update to a Safety Communication on the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure. Read more: https://go.usa.gov/xEfkX  #MedicalDev

Today @US_FDA made an update to a Safety Communication on the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure. Read more: https://go.usa.gov/xEfkX  #MedicalDevice #FDA pic.twitter.com/WZZjTq0BMX

FDA - U.S. Food and Drug Administration

6-3-2019

Consultation: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems

Consultation: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

6-3-2019

Consultation: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin

Consultation: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

6-3-2019

Consultation: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media

Consultation: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

6-3-2019

Consultation: Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation

Consultation: Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation

This consultation considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

6-3-2019

Consultation: Proposed changes to the classification of active implantable medical devices and their accessories

Consultation: Proposed changes to the classification of active implantable medical devices and their accessories

This consultation considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

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

28-2-2019

Today @US_FDA issued a safety communication to providers and patients  about the use of robotically-assisted surgical devices for mastectomy  and other cancer related surgeries. Read more here:  https://go.usa.gov/xEpub?utm_source=CDRHTwitterD …  #Medical

Today @US_FDA issued a safety communication to providers and patients about the use of robotically-assisted surgical devices for mastectomy and other cancer related surgeries. Read more here: https://go.usa.gov/xEpub?utm_source=CDRHTwitterD … #Medical

Today @US_FDA issued a safety communication to providers and patients about the use of robotically-assisted surgical devices for mastectomy and other cancer related surgeries. Read more here: https://go.usa.gov/xEpub?utm_source=CDRHTwitterD … #MedicalDevice pic.twitter.com/MitGy4EuFh

FDA - U.S. Food and Drug Administration

28-2-2019

If a person has cardiac arrest, rapid treatment with a #medicaldevice called an automated external defibrillator (AED) can be life-saving. Here's how. link:  https://go.usa.gov/xEpzJ?utm_source=CDRHTwitterD … #heartmonthpic.twitter.com/fmj3uU8yb7

If a person has cardiac arrest, rapid treatment with a #medicaldevice called an automated external defibrillator (AED) can be life-saving. Here's how. link: https://go.usa.gov/xEpzJ?utm_source=CDRHTwitterD … #heartmonthpic.twitter.com/fmj3uU8yb7

If a person has cardiac arrest, rapid treatment with a #medicaldevice called an automated external defibrillator (AED) can be life-saving. Here's how. link: https://go.usa.gov/xEpzJ?utm_source=CDRHTwitterD … #heartmonth pic.twitter.com/fmj3uU8yb7

FDA - U.S. Food and Drug Administration

26-2-2019

TGA presentation: Stakeholder Workshop held in TGA, Symonston, 8 February 2019

TGA presentation: Stakeholder Workshop held in TGA, Symonston, 8 February 2019

This presentation highlights some of the concerns related to system or procedure pack medical devices.

Therapeutic Goods Administration - Australia