DIFFLAM PLUS ANAESTHETIC SORE THROAT LOZENGES pineapple & lime flavour blister pack

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
benzydamine hydrochloride,dichlorobenzyl alcohol,lidocaine (lignocaine) hydrochloride monohydrate
Available from:
iNova Pharmaceuticals (Australia) Pty Ltd
Authorization status:
Registered
Authorization number:
323563

Public Summary

Summary for ARTG Entry:

323563

DIFFLAM PLUS ANAESTHETIC SORE THROAT LOZENGES pineapple & lime flavour blister pack

ARTG entry for

Medicine Registered

Sponsor

iNova Pharmaceuticals (Australia) Pty Ltd

Postal Address

PO Box 5033,WEST CHATSWOOD, NSW, 1515

Australia

ARTG Start Date

16/09/2019

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. DIFFLAM PLUS ANAESTHETIC SORE THROAT LOZENGES pineapple & lime flavour blister pack

Product Type

Single Medicine Product

Effective date

16/09/2019

Permitted Indications

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

For the relief of major symptoms associated with sore throat. Reduces inflammation and relieves pain for fast effective relief of symptoms of a sore

throat, pharyngitis, tonsilitis, mouth ulcers, minor mouth infections, pain following throat surgery, mouth surgery or dental procedures, swelling, redness

and inflammatory conditions

Warnings

No Warnings included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

36 Months

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

16 lozenges

Not Scheduled after consideration by Committee

2 lozenges

Not Scheduled after consideration by Committee

Components

1.

Dosage Form

Lozenge

Route of Administration

Buccal

Oral

Visual Identification

Light yellowish green colour to yellow green coloured, round lozenges

Active Ingredients

benzydamine hydrochloride

3 mg

dichlorobenzyl alcohol

1.2 mg

lidocaine (lignocaine) hydrochloride monohydrate

4 mg

Public Summary

Page 1 of

Produced at 29.09.2019 at 04:43:04 AEST

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 29.09.2019 at 04:43:04 AEST

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

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