HEDAFEN

Main information

  • Trade name:
  • HEDAFEN IBUPROFEN 200 mg soft gelatin capsule blister pack (red capsules)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • HEDAFEN IBUPROFEN 200 mg soft gelatin capsule blister pack (red capsules)
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210582
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210582

HEDAFEN IBUPROFEN 200 mg soft gelatin capsule blister pack (red capsules)

ARTG entry for

Medicine Registered

Sponsor

Nova Pharmaceuticals Australasia Pty Ltd

Postal Address

Suite 305 / 10 Norbrik Drive,BELLA VISTA, NSW, 2153

Australia

ARTG Start Date

5/06/2013

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. HEDAFEN IBUPROFEN 200 mg soft gelatin capsule blister pack (red capsules)

Product Type

Single Medicine Product

Effective date

13/10/2015

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For the effective and temporary relief of pain, discomfort and inflammation associated with migraine and tension headache, muscular aches, dental pain,

aches and pains associated with colds and flu, period pain, arthritic pain. Reduces fever.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

36 Months

Store below 25

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Not scheduled. Not considered by committee

Components

1.

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Wine red colour, oval shaped soft gelatin capsules containing colourless to

pale yellow coloured, viscous liquid, printed '142' in white colour on capsule

shell

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 27.11.2017 at 09:23:20 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

21-2-2017

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