COPARADEINE

Main information

  • Trade name:
  • COPARADEINE FORTE 500 / 30 paracetamol / codeine phosphate hemihydrate 500mg / 30mg tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COPARADEINE FORTE 500 / 30 paracetamol / codeine phosphate hemihydrate 500mg / 30mg tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220978
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220978

COPARADEINE FORTE 500 / 30 paracetamol / codeine phosphate hemihydrate 500mg / 30mg tablets

blister pack

ARTG entry for

Medicine Registered

Sponsor

Generic Partners Pty Ltd

Postal Address

Level 1 / 313 Burwood Road,Hawthorn, VIC, 3122

Australia

ARTG Start Date

13/03/2015

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

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. COPARADEINE FORTE 500 / 30 paracetamol / codeine phosphate hemihydrate 500mg / 30mg tablets blister

pack

Product Type

Single Medicine Product

Effective date

14/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Relief of moderate to severe pain, and fever

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

60 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. COPARADEINE FORTE 500 / 30 paracetamol / codeine phosphate hemihydrate 500mg / 30mg tablets blister pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White, round and scored tablets

Active Ingredients

codeine phosphate hemihydrate

30 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 26.11.2017 at 01:47:04 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

18-2-2019

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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.

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