RAFEN PLUS ibuprofen 200mg and codeine phosphate hemihydrate 12.8mg film coated tablet, blister pack

Main information

  • Trade name:
  • RAFEN PLUS ibuprofen 200mg and codeine phosphate hemihydrate 12.8mg film coated tablet, blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RAFEN PLUS ibuprofen 200mg and codeine phosphate hemihydrate 12.8mg film coated tablet, blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 178744
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

178744

RAFEN PLUS ibuprofen 200mg and codeine phosphate hemihydrate 12.8mg film coated tablet, blister pack

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

24/12/2010

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. RAFEN PLUS ibuprofen 200mg and codeine phosphate hemihydrate 12.8mg film coated tablet, blister pack

Product Type

Single Medicine Product

Effective date

9/01/2013

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For temporary relief of strong pain and/or inflammation associated with headache (including migraine and tension headache), period pain, dental pain,

back pain, neuralgia, rheumatic and arthritic pain, muscular pain.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC

36 Months

Store below 30

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S3) Pharmacist Only Medicine

(S3) Pharmacist Only Medicine

(S3) Pharmacist Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

white to off-white capsule-shaped, biconvex, film-coated tablet

Active Ingredients

codeine phosphate hemihydrate

12.8 mg

Ibuprofen

200 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 29.11.2017 at 10:05:33 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