MEDI

Main information

  • Trade name:
  • MEDI CHOICE HEARTBURN & ACID INDIGESTION ranitidine hydrochloride 167.5mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MEDI CHOICE HEARTBURN & ACID INDIGESTION ranitidine hydrochloride 167.5mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210007
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210007

MEDI CHOICE HEARTBURN & ACID INDIGESTION ranitidine hydrochloride 167.5mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Nova Pharmaceuticals Australasia Pty Ltd

Postal Address

Suite 305 / 10 Norbrik Drive,BELLA VISTA, NSW, 2153

Australia

ARTG Start Date

23/05/2013

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. MEDI CHOICE HEARTBURN & ACID INDIGESTION ranitidine hydrochloride 167.5mg tablet blister pack

Product Type

Single Medicine Product

Effective date

23/05/2013

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Provides effective long-lasting 12-hour relief from heartburn and acid indigestion due to gastro-oesophageal reflux.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

36 Months

Store below 25

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Not scheduled. Not considered by committee

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Creamish to yellowish coloured, convex, film-coated tablet, impressed with

the identifying letters 'R' and 'I' on either side of a central division line on

one face.

Active Ingredients

Ranitidine hydrochloride

167.5 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 1 of

Produced at 27.11.2017 at 10:06:59 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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Europe -DG Health and Food Safety

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Europe -DG Health and Food Safety

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Europe -DG Health and Food Safety

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14-3-2019


Nitrous oxide, nitrous oxide / oxygen: List of nationally authorised medicinal products - PSUSA/00010572/201806

Nitrous oxide, nitrous oxide / oxygen: List of nationally authorised medicinal products - PSUSA/00010572/201806

Nitrous oxide, nitrous oxide / oxygen: List of nationally authorised medicinal products - PSUSA/00010572/201806

Europe - EMA - European Medicines Agency

14-3-2019


Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

14-3-2019

Aivlosin (ECO Animal Health Europe Limited)

Aivlosin (ECO Animal Health Europe Limited)

Aivlosin (Active substance: Tylvalosin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2091 of Thu, 14 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/83/T/77

Europe -DG Health and Food Safety

14-3-2019

Reconcile (Pegasus Laboratories Ireland Limited)

Reconcile (Pegasus Laboratories Ireland Limited)

Reconcile (Active substance: Fluoxetine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2089 of Thu, 14 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/133/T/31

Europe -DG Health and Food Safety

14-3-2019


Milnacipran: List of nationally authorised medicinal products - PSUSA/00002063/201804

Milnacipran: List of nationally authorised medicinal products - PSUSA/00002063/201804

Milnacipran: List of nationally authorised medicinal products - PSUSA/00002063/201804

Europe - EMA - European Medicines Agency

14-3-2019

Webinar: Permitted indications for listed medicines

Webinar: Permitted indications for listed medicines

Webinar for small to medium businesses, start-ups, researchers and those new to regulation

Therapeutic Goods Administration - Australia

13-3-2019


Loperamide, loperamide / simeticone: List of nationally authorised medicinal products - PSUSA/00010665/201805

Loperamide, loperamide / simeticone: List of nationally authorised medicinal products - PSUSA/00010665/201805

Loperamide, loperamide / simeticone: List of nationally authorised medicinal products - PSUSA/00010665/201805

Europe - EMA - European Medicines Agency

13-3-2019

Luminity (Lantheus EU Limited)

Luminity (Lantheus EU Limited)

Luminity (Active substance: perflutren) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2049 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/654/T/27

Europe -DG Health and Food Safety