Enerzair Breezhaler *

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 25 August 2021

File name

Enerzair Breezhaler_REG SPC_PF21-0084_July 2021_IPHA_1629884745.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of information to Section 5.1 Pharmacodynamic Properties:

Comparison of Enerzair Breezhaler to the concurrent open-label administration of salmeterol/fluticasone + tiotropium
A randomised, partially-blinded, active-treatment-controlled, non-inferiority study (ARGON) comparing Enerzair Breezhaler 114 mcg/46 mcg/136 mcg once daily (N=476) and 114 mcg/46 mcg/68 mcg once daily (N=474) to the concurrent administration of salmeterol/fluticasone propionate 50 mcg/500 mcg twice daily + tiotropium 5 mcg once daily (N=475) over 24 weeks of treatment was conducted.
Enerzair Breezhaler demonstrated non-inferiority to salmeterol/fluticasone + tiotropium for the primary endpoint (change from baseline for Asthma Quality of Life Questionnaire [AQLQ-S]), in previously symptomatic patients on ICS and LABA therapy with a difference of 0.073 (one-sided lower 97.5% confidence limit [CL]: -0.027).

 

Updated on 04 May 2021

File name

Enerzair Breezhaler_REG SPC_PF21-0102_April 2021_IPHA_1620123630.pdf

Reasons for updating

  • Other

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 04 May 2021

File name

Enerzair Breezhaler_REG PIL_PF21-0102_Clean_1620123525.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to other sources of information section

Updated on 30 October 2020

File name

Enerzair Breezhaler_REG PIL_PF20-0093_Clean_IPHA_1604072106.pdf

Reasons for updating

  • New PIL for new product

Updated on 30 October 2020

File name

Enerzair Breezhaler_REG SPC_PF20-0093_July 2020_IPHA_1604071951.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)