SALBUTAMOL-PS salbutamol (as sulfate) 2.5mg/2.5mL inhalation solution ampoule

Main information

  • Trade name:
  • SALBUTAMOL-PS salbutamol (as sulfate) 2.5mg/2.5mL inhalation solution ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SALBUTAMOL-PS salbutamol (as sulfate) 2.5mg/2.5mL inhalation solution ampoule
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 189848
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

189848

SALBUTAMOL-PS salbutamol (as sulfate) 2.5mg/2.5mL inhalation solution ampoule

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

13/07/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Conditions Applying to Therapeutic Goods

Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989"

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 February 1992, other than condition No. 8 and condition No. 9.

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 February 1992, other than condition No. 11.

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods

on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to

substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription

Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

The conditions applying to these goods when they are exported from Australia are given below:

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. SALBUTAMOL-PS salbutamol (as sulfate) 2.5mg/2.5mL inhalation solution ampoule

Product Type

Single Medicine Product

Effective date

4/06/2013

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

For the relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease, and for acute prophylaxis against exercise-induced

asthma or in other situations known to induce bronchospasm.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

LDPE

3 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

30 nebules of 2.5mL each

(S4) Prescription Only Medicine

Components

1. SALBUTAMOL-PS salbutamol (as sulfate) 2.5mg/2.5mL inhalation solution ampoule

Dosage Form

Inhalation

Route of Administration

Inhalation

Visual Identification

Colourless solution in clear plastic ampoules

Active Ingredients

salbutamol sulfate

1.2 mg/mL

Public Summary

Page 1 of

Produced at 29.11.2017 at 12:08:21 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 29.11.2017 at 12:08:21 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