ATROVENT

Main information

  • Trade name:
  • ATROVENT NASAL FORTE ipratropium bromide monohydrate 44 microgram/actuation spray solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ATROVENT NASAL FORTE ipratropium bromide monohydrate 44 microgram/actuation spray solution
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 67490
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

67490

ATROVENT NASAL FORTE ipratropium bromide monohydrate 44 microgram/actuation spray solution

ARTG entry for

Medicine Registered

Sponsor

Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare

Postal Address

PO Box 403,VIRGINIA, QLD, 4014

Australia

ARTG Start Date

25/05/1999

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. ATROVENT NASAL FORTE ipratropium bromide monohydrate 44 microgram/actuation spray solution

Product Type

Single Medicine Product

Effective date

29/08/2017

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For the symptomatic relief of rhinorrhoea associated with allergic and non-allergic perennial rhinitis, and the common cold.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Aerosol - Pump

Actuated Metered

Dose

Not recorded

2 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(180 metered doses) 15mL

(S2) Pharmacy Medicine

(120 metered doses) 10mL

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Spray, solution

Route of Administration

Nasal

Visual Identification

Clear, colourless or almost colourless liquid, practically free from particles.

Active Ingredients

ipratropium bromide

.6 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 10:47:05 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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