DIMETAPP

Main information

  • Trade name:
  • DIMETAPP CHILDREN'S PAIN AND FEVER RELIEF IBUPROFEN 100mg/5mL oral liquid - suspension bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIMETAPP CHILDREN'S PAIN AND FEVER RELIEF IBUPROFEN 100mg/5mL oral liquid - suspension bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 90104
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

90104

DIMETAPP CHILDREN'S PAIN AND FEVER RELIEF IBUPROFEN 100mg/5mL oral liquid - suspension

bottle

ARTG entry for

Medicine Registered

Sponsor

Pfizer Australia Pty Ltd

Postal Address

38-42 Wharf Road,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

16/07/2002

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

Products

1. DIMETAPP CHILDREN'S PAIN AND FEVER RELIEF IBUPROFEN 100mg/5mL oral liquid - suspension bottle

Product Type

Single Medicine Product

Effective date

3/05/2010

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Temporary relief of pain and discomfort associated with common colds and flu, sore throat, earache, headache, toothache and body aches and pains in

children 3 months to 12 years. Reduces fever.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

200mL

(S2) Pharmacy Medicine

100mL

(S2) Pharmacy Medicine

25 mL

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Oral Liquid, suspension

Route of Administration

Oral

Visual Identification

White to off white suspension with banana odour

Active Ingredients

Ibuprofen

20 mg/mL

© 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 01.12.2017 at 08:10:34 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

30-1-2019

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

FDA - U.S. Food and Drug Administration

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

21-2-2017

Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets

Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets

Takeda Pharma A/S recalls a batch of Pamol® in packs of 300 film-coated tablets after the discovery of Ibumetin 600 mg containing ibuprofen in some packs. Both types of medicine are used for the treatment of mild pain, but they work in different ways and may cause different adverse reactions.

Danish Medicines Agency

20-2-2019


Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/20180

Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/20180

Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/20180

Europe - EMA - European Medicines Agency

13-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, decision type: , therapeutic area: , PIP number: P/0382/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, decision type: , therapeutic area: , PIP number: P/0382/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, decision type: , therapeutic area: , PIP number: P/0382/2018

Europe - EMA - European Medicines Agency

4-12-2018


Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen,Paracetamol, decision type: , therapeutic area: , PIP number: P/0135/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen,Paracetamol, decision type: , therapeutic area: , PIP number: P/0135/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen,Paracetamol, decision type: , therapeutic area: , PIP number: P/0135/2018

Europe - EMA - European Medicines Agency

24-5-2018

Pedea (Orphan Europe S.A.R.L.)

Pedea (Orphan Europe S.A.R.L.)

Pedea (Active substance: Ibuprofen) - PSUSA - Modification - Commission Decision (2018)3257 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/1712/201707

Europe -DG Health and Food Safety