NASONEX

Main information

  • Trade name:
  • NASONEX ALLERGY mometasone furoate 50 micrograms/ actuation (as monohydrate) aqueous nasal spray
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NASONEX ALLERGY mometasone furoate 50 micrograms/ actuation (as monohydrate) aqueous nasal spray
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215798
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215798

NASONEX ALLERGY mometasone furoate 50 micrograms/ actuation (as monohydrate) aqueous nasal

spray

ARTG entry for

Medicine Registered

Sponsor

Bayer Australia Ltd

Postal Address

PO Box 182,Gordon NSW 2072,Gordon, NSW, 2072

Australia

ARTG Start Date

9/10/2013

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. NASONEX ALLERGY mometasone furoate 50 micrograms/ actuation (as monohydrate) aqueous nasal

spray

Product Type

Single Medicine Product

Effective date

12/12/2016

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For the prophylaxis or treatment of allergic rhinitis for up to six months in adults and children 12 years of age and over

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S2) Pharmacy Medicine

(S2) Pharmacy Medicine

(S2) Pharmacy Medicine

140x2

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Spray, suspension

Route of Administration

Nasal

Visual Identification

White to off-white opaque suspension.

Active Ingredients

mometasone furoate

50 microgram/actuation

© 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 26.11.2017 at 08:09:45 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

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