PHARMACY

Main information

  • Trade name:
  • PHARMACY ACTION Ibuprofen 200mg tablet bister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PHARMACY ACTION Ibuprofen 200mg tablet bister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 196020
  • Last update:
  • 12-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

196020

PHARMACY ACTION Ibuprofen 200mg tablet bister pack

ARTG entry for

Medicine Registered

Sponsor

Generic Health Pty Ltd

Postal Address

Level 1 / 1102 Toorak Road,CAMBERWELL, VIC, 3124

Australia

ARTG Start Date

26/03/2012

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. PHARMACY ACTION Ibuprofen 200mg tablet bister pack

Product Type

Single Medicine Product

Effective date

15/11/2012

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Provides fast and temporary relief of headache, backache, minor arthritic pain, dental pain and period pain. Temporary relief of muscle pain where

inflammation is present.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Not recorded

3 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

40 tablets

(S2) Pharmacy Medicine

10 tablets

Not scheduled. Not considered by committee

24 Tablets

Not scheduled. Not considered by committee

30 tablets

(S2) Pharmacy Medicine

48 Tablets

(S2) Pharmacy Medicine

96 Tablets

(S2) Pharmacy Medicine

100 tablets

(S2) Pharmacy Medicine

20 tablets

Not scheduled. Not considered by committee

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White/Offwhite circular biconvex film-coated tablet.

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 28.11.2017 at 03:10:35 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