SOUL

Main information

  • Trade name:
  • SOUL PATTINSON COLOURFREE CHILDREN'S PARACETAMOL SUSPENSION CONCENTRATED 5-12 YEARS paracetamol
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SOUL PATTINSON COLOURFREE CHILDREN'S PARACETAMOL SUSPENSION CONCENTRATED 5-12 YEARS paracetamol
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 74522
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

74522

SOUL PATTINSON COLOURFREE CHILDREN'S PARACETAMOL SUSPENSION CONCENTRATED

5-12 YEARS paracetamol

ARTG entry for

Medicine Registered

Sponsor

Soul Pattinson Manufacturing Pty Ltd

Postal Address

Locked Bag 5061,PARRAMATTA, NSW, 2124

Australia

ARTG Start Date

26/06/2000

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. SOUL PATTINSON COLOURFREE CHILDREN'S PARACETAMOL SUSPENSION CONCENTRATED 5-12

YEARS paracetamol

Product Type

Single Medicine Product

Effective date

4/02/2016

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Temporary relief of pain and fever.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

2 Years

Store below 25

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

200mL

(S2) Pharmacy Medicine

100mL

(S2) Pharmacy Medicine

500mL

(S2) Pharmacy Medicine

50mL

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Suspension

Route of Administration

Oral

Visual Identification

Smooth, off white suspension.

Active Ingredients

Paracetamol

48 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 08:41:32 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

27-2-2014

Paracetamol use during pregnancy

Paracetamol use during pregnancy

A new Danish study suggests a possible connection between mothers' use of paracetamol painkillers during pregnancy and the risk of developing disorders like ADHD (attention deficit hyperactivity disorder) in children.

Danish Medicines Agency

3-8-2012

Danish Pharmacovigilance Update, 21 June 2012

Danish Pharmacovigilance Update, 21 June 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Decrease in the number of intoxications and suicide attempts using drugs containing acetylsalicylic acid or paracetamol.

Danish 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

30-8-2018

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'. Closing date 31 October 2018

Therapeutic Goods Administration - Australia

30-8-2018

Modified release paracetamol

Modified release paracetamol

Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'

Therapeutic Goods Administration - Australia