MEDIHEALTH IBUPROFEN ibuprofen 200mg tablet bottle

Main information

  • Trade name:
  • MEDIHEALTH IBUPROFEN ibuprofen 200mg tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MEDIHEALTH IBUPROFEN ibuprofen 200mg tablet bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 188987
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

188987

MEDIHEALTH IBUPROFEN ibuprofen 200mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Orion Laboratories Pty Ltd T/A Perrigo Australia

Postal Address

25-29 Delawney Street,BALCATTA, WA, 6021

Australia

ARTG Start Date

8/09/2011

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. MEDIHEALTH IBUPROFEN ibuprofen 200mg tablet bottle

Product Type

Single Medicine Product

Effective date

12/01/2012

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Temporarily relieves minor aches and pains due to headache, minor pain of arthritis, common cold, muscular aches, toothache, menstrual cramps and

backache. Temporarily reduces fever.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

36 Months

Store below 25

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S2) Pharmacy Medicine

Not scheduled. Not considered by committee

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

A brown film coated, biconvex tablet having the logo "I-2" debossed into

one face with a slight characterisitic ibuprofen odour.

Active Ingredients

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 12:45:58 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