MEDREICH

Main information

  • Trade name:
  • MEDREICH PARACETAMOL 500MG AND CODEINE PHOSPHATE 8MG tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MEDREICH PARACETAMOL 500MG AND CODEINE PHOSPHATE 8MG tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211368
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211368

MEDREICH PARACETAMOL 500MG AND CODEINE PHOSPHATE 8MG tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Medreich Australia Pty Ltd

Postal Address

PO Box 6549,SILVERWATER, NSW, 1811

Australia

ARTG Start Date

24/06/2013

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. MEDREICH PARACETAMOL 500MG AND CODEINE PHOSPHATE 8MG tablets blister pack

Product Type

Single Medicine Product

Effective date

9/11/2015

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Fast effective temporary relief of strong pain including migraine headache, toothache, period pain and minor arthritic pain. Reduces fever.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

36 Months

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S3) Pharmacist Only Medicine

(S3) Pharmacist Only Medicine

(S3) Pharmacist Only Medicine

(S3) Pharmacist Only Medicine

(S3) Pharmacist Only Medicine

(S3) Pharmacist Only Medicine

(S3) Pharmacist Only Medicine

Components

1.

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

Pink, circular, flat beveled tablets with central break line on one side and

plain on other side

Active Ingredients

codeine phosphate hemihydrate

8 mg

Paracetamol

500 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 01:31:23 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

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

Europe - EFSA - European Food Safety Authority Publications

16-1-2018

Yunnan Feng Shi Ling capsules – counterfeit

Yunnan Feng Shi Ling capsules – counterfeit

Yunnan Feng Shi Ling capsules contain the undeclared substance paracetamol.

Therapeutic Goods Administration - Australia

16-11-2017

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

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

Ibrutinib - ventricular tachyarrhythmia, hepatitis B reactivation and infection; Improving Product Information; Codeine-containing products - use in children and ultra-rapid metabolisers

Therapeutic Goods Administration - Australia

27-2-2014

Paracetamol use during pregnancy

Paracetamol use during pregnancy

A new Danish study suggests a possible connection between mothers' use of paracetamol painkillers during pregnancy and the risk of developing disorders like ADHD (attention deficit hyperactivity disorder) in children.

Danish Medicines Agency

3-8-2012

Danish Pharmacovigilance Update, 21 June 2012

Danish Pharmacovigilance Update, 21 June 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Decrease in the number of intoxications and suicide attempts using drugs containing acetylsalicylic acid or paracetamol.

Danish Medicines Agency

26-8-2011

Reassessment of reimbursement status of strong analgesics (opioids) – methadone and codeine

Reassessment of reimbursement status of strong analgesics (opioids) – methadone and codeine

On 15 August 2011, the Danish Medicines Agency announced that we would begin reassessing the reimbursement status of medicines in ATC group N02A, opioids. The Reimbursement Committee opened its preliminary discussions at its meeting on 23 August 2011 and recommended to include the opioids methadone (N07BC02) and codeine (R05DA04), also used in pain management, in the reassessment of reimbursement status of medicinal products in ATC group N02A.

Danish Medicines Agency

30-8-2018

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'. Closing date 31 October 2018

Therapeutic Goods Administration - Australia

30-8-2018

Modified release paracetamol

Modified release paracetamol

Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'

Therapeutic Goods Administration - Australia

10-8-2018

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Active substance: tedizolid phosphate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5522 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2846/T/28

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2047 (Glycomine SARL)

EU/3/18/2047 (Glycomine SARL)

EU/3/18/2047 (Active substance: Liposomal mannose-1-phosphate) - Orphan designation - Commission Decision (2018)5279 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/055/18

Europe -DG Health and Food Safety

27-6-2018

EU/3/02/124 (BioMarin International Limited)

EU/3/02/124 (BioMarin International Limited)

EU/3/02/124 (Active substance: 3,4-diaminopyridine phosphate) - Transfer of orphan designation - Commission Decision (2018)4095 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/050/02/T/03

Europe -DG Health and Food Safety

1-6-2018

hydrocodone (Vicodin®), codeine, morphine, and many others. #DYK #FDAInnovationChallenge (2 of 2 messages)  https://go.usa.gov/xQwmW pic.twitter.com/bGlnTFOzVE

hydrocodone (Vicodin®), codeine, morphine, and many others. #DYK #FDAInnovationChallenge (2 of 2 messages) https://go.usa.gov/xQwmW pic.twitter.com/bGlnTFOzVE

hydrocodone (Vicodin®), codeine, morphine, and many others. #DYK #FDAInnovationChallenge (2 of 2 messages) https://go.usa.gov/xQwmW  pic.twitter.com/bGlnTFOzVE

FDA - U.S. Food and Drug Administration