Enerzair Breezhaler *
Pharmacy Only: Prescription

Updated on 19 November 2021

File name

Enerzair Breezhaler_REG PIL_PF21-0278_Clean_1637325130.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 19 November 2021

File name

Enerzair Breezhaler_REG SPC_November 2021_IPHA_1637325080.pdf

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

Added:

Do not store above 30°C.

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)