CHEMMART

Main information

  • Trade name:
  • CHEMMART PHARMACY COLD & FLU + COUGH DAY & NIGHT capsules blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CHEMMART PHARMACY COLD & FLU + COUGH DAY & NIGHT capsules blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217094
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217094

CHEMMART PHARMACY COLD & FLU + COUGH DAY & NIGHT capsules blister pack

ARTG entry for

Medicine Registered

Sponsor

Symbion Pty Ltd

Postal Address

PO Box 7300,Melbourne, VIC, 3008

Australia

ARTG Start Date

11/11/2013

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. CHEMMART PHARMACY COLD & FLU + COUGH DAY & NIGHT capsules blister pack

Product Type

Composite Pack

Effective date

11/11/2013

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Temporary relief of cold and flu symptoms, including headaches, body aches and pains, blocked nose, runny nose and dry irritated coughs. Reduces

fever.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Multiple containers

Not recorded

36 Months

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S2) Pharmacy Medicine

(S2) Pharmacy Medicine

Components

1. Chemmart Pharmacy Paracetamol 500mg, Chlorpheniramine Maleate 2mg, Dextromethorphan Hydrobromide 10mg Capsules

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Hard gelatin capsules of size '0' having white coloured body and red

coloured cap contains white to off-white crystalline powder

Active Ingredients

chlorphenamine maleate

2 mg

dextromethorphan hydrobromide monohydrate

10 mg

Paracetamol

500 mg

2. Chemmart Pharmacy Paracetamol 500, Dextromethorphan hydrobromide 10mg, Phenylephrine hydrochloride 5mg

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Hard gelatin capsule of size '0' having blue coloured body and blue cap

contains white crystalline powder

Active Ingredients

dextromethorphan hydrobromide monohydrate

10 mg

Paracetamol

500 mg

Phenylephrine hydrochloride

5 mg

Public Summary

Page 1 of

Produced at 26.11.2017 at 06:56:18 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

© 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 2 of

Produced at 26.11.2017 at 06:56:18 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

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety