INCRUSE

Main information

  • Trade name:
  • INCRUSE ELLIPTA umeclidinium (as bromide) 62.5 microgram powder for inhalation
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • INCRUSE ELLIPTA umeclidinium (as bromide) 62.5 microgram powder for inhalation
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211601
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211601

INCRUSE ELLIPTA umeclidinium (as bromide) 62.5 microgram powder for inhalation

ARTG entry for

Medicine Registered

Sponsor

GlaxoSmithKline Australia Pty Ltd

Postal Address

PO Box 18095,Melbourne, VIC, 8003

Australia

ARTG Start Date

8/07/2014

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. INCRUSE ELLIPTA umeclidinium (as bromide) 62.5 microgram powder for inhalation

Product Type

Single Medicine Product

Effective date

15/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Incruse Ellipta is indicated as a long term once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive

pulmonary disease (COPD)

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Inhaler - dry powder

Other plastic

laminate/Al

24 Months

Store below 30

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

See Product

information for shelf

life

Pack Size/Poison information

Pack Size

Poison Schedule

7 (sample pack)

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. INCRUSE ELLIPTA umeclidinium (as bromide) 62.5 microgram powder for inhalation

Dosage Form

Inhalation, powder for

Route of Administration

Inhalation

Visual Identification

A plastic inhaler with a light grey body and a light green mouthpiece cover

containing one strip of blister containing a white powder.

Active Ingredients

umeclidinium bromide

74.2 microgram

© 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 01:17:15 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

6-11-2018

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Tovanor Breezhaler (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4526 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2690/T/30

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Enurev Breezhaler (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4342 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2691/T/27

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Rolufta (Active substance: umeclidinium) - Centralised - Yearly update - Commission Decision (2018)4017 of Mon, 25 Jun 2018

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14-6-2018

Incruse (Glaxo Group Ltd)

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Incruse (Active substance: umeclidinium bromide) - Centralised - Yearly update - Commission Decision (2018)3855 of Thu, 14 Jun 2018

Europe -DG Health and Food Safety

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Ultibro Breezhaler (Novartis Europharm Limited)

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Ultibro Breezhaler (Active substance: indacaterol/glycopyrronium bromide) - Centralised - Renewal - Commission Decision (2018)3259 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2679/R/24

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Xoterna Breezhaler (Novartis Europharm Limited)

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Xoterna Breezhaler (Active substance: indacaterol/glycopyrronium bromide) - Centralised - Renewal - Commission Decision (2018)3265 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3755/R/27

Europe -DG Health and Food Safety

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Ulunar Breezhaler (Novartis Europharm Limited)

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Ulunar Breezhaler (Active substance: indacaterol/glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3058 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3875/T/24

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Trydonis (Active substance: beclometasone / formoterol / glycopyrronium bromide) - Centralised - Authorisation - Commission Decision (2018)2713 of Wed, 02 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4702

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