EVOCAIR

Main information

  • Trade name:
  • EVOCAIR MDI 250/25 fluticasone propionate 250 mcg/salmeterol (as xinafoate) 25 mcg inhalation pressurised aerosol can metered do
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EVOCAIR MDI 250/25 fluticasone propionate 250 mcg/salmeterol (as xinafoate) 25 mcg inhalation pressurised aerosol can metered do
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 208668
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

208668

EVOCAIR MDI 250/25 fluticasone propionate 250 mcg/salmeterol (as xinafoate) 25 mcg inhalation

pressurised aerosol can metered dose (with counter)

ARTG entry for

Medicine Registered

Sponsor

GlaxoSmithKline Australia Pty Ltd

Postal Address

PO Box 18095,Melbourne, VIC, 8003

Australia

ARTG Start Date

7/05/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

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. EVOCAIR MDI 250/25 fluticasone propionate 250 mcg/salmeterol (as xinafoate) 25 mcg inhalation

pressurised aerosol can metered dose (with counter)

Product Type

Single Medicine Product

Effective date

8/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

For the regular treatment of asthma, where the use of a combination product is appropriate. This may include:,*Patients on effective maintenance doses

of long-acting beta2-agonists and inhaled corticosteroids.,*Patients who are symptomatic on current inhaled corticosteroid therapy.,For the symptomatic

treatment of patients with severe COPD (FEV1<50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite

regular beta-2 agonist bronchodilator therapy. Evocair is not indicated for the initiation of bronchodilator therapy in COPD.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Aerosol Can -

Metered Dose

2 Years

Store below 30

degrees Celsius

Not recorded

Protect from direct

sunlight

Pack Size/Poison information

Pack Size

Poison Schedule

120 doses

(S4) Prescription Only Medicine

Sample Pack

(S4) Prescription Only Medicine

Components

1. EVOCAIR MDI 250/25 fluticasone propionate 250 mcg/salmeterol (as xinafoate) 25 mcg inhalation pressurised aerosol can metered dose

(with counter)

Dosage Form

Inhalation, pressurised

Route of Administration

Inhalation

Visual Identification

Actuator & metal can with concave base fitted with a metering valve and a

plastic doese counter. The canister contains a white to off-white

suspension. The internal surfaces of the can & the valve are free from

obvious defects.

Active Ingredients

fluticasone propionate

250 microgram/actuation

Salmeterol xinafoate

36.3 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 27.11.2017 at 11:04:14 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

18-10-2018

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Health Canada seized “Surfaz-SN Triple Action Cream”—an unauthorized skin cream promoted for antifungal, antibacterial and anti-inflammatory use—because it is labelled to contain prescription drugs (betamethasone dipropionate and neomycin sulphate). The product was seized from Kaf African Caribbean Market (2642 Liruma Road, Unit 2A) in Mississauga, Ontario.

Health Canada

1-8-2018

Unauthorized skin creams and lotions sold at various retailers in Quebec may pose serious health risks

Unauthorized skin creams and lotions sold at various retailers in Quebec may pose serious health risks

Health Canada seized eight unauthorized skin lotions and creams from Ayotai Canada because they are labelled to contain a prescription drug (clobetasol propionate or betamethasone dipropionate). The unauthorized lotions and creams were distributed by Ayotai and sold by various retailers in Quebec.

Health Canada

31-5-2018

Fluticasone Propionate Nasal Spray by Apotex Corp: Recall - Due to Potential for Small Glass Particles

Fluticasone Propionate Nasal Spray by Apotex Corp: Recall - Due to Potential for Small Glass Particles

The glass particles could block the actuator and impact the functionality of the pump and expose patients to the glass particles.

FDA - U.S. Food and Drug Administration

31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

FDA - U.S. Food and Drug Administration

6-11-2018

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7416 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4363/WS/1369

Europe -DG Health and Food Safety

6-11-2018

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7417 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4781/WS/1369

Europe -DG Health and Food Safety

3-7-2018

Revinty Ellipta (Glaxo Group Ltd)

Revinty Ellipta (Glaxo Group Ltd)

Revinty Ellipta (Active substance: fluticasone furoate / vilanterol) - Corrigendum - Commission Decision (2014)3040 of Tue, 03 Jul 2018

Europe -DG Health and Food Safety

3-7-2018

Relvar Ellipta (Glaxo Group Ltd)

Relvar Ellipta (Glaxo Group Ltd)

Relvar Ellipta (Active substance: fluticasone furoate/vilanterol) - Corrigendum - Commission Decision (2013)8089 of Tue, 03 Jul 2018

Europe -DG Health and Food Safety

3-5-2018

Avamys (Glaxo Group Ltd)

Avamys (Glaxo Group Ltd)

Avamys (Active substance: Fluticasone furoate) - Centralised - Yearly update - Commission Decision (2018)2773 of Thu, 03 May 2018

Europe -DG Health and Food Safety