Enerzair Breezhaler 114 micrograms/46 micrograms/136 micrograms inhalation powder, hard capsules
*Company:
Novartis Ireland LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 29 October 2024
File name
Enerzair Breezhaler 114 micrograms_REG SPC_PF24-0208_04.09.2024_clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 October 2023
File name
Enerzair Breezhaler 114 micrograms46 m_PIL_07.09.2023_clean.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 25 October 2023
File name
Enerzair Breezhaler 114 micrograms46 m_SMPC_07.09.2023_clean.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 October 2023
File name
Enerzair Breezhaler 114 micrograms46 m_PIL_07.09.2023_clean.pdf
Reasons for updating
- Change to storage instructions
Updated on 25 October 2023
File name
Enerzair Breezhaler 114 micrograms46 m_PIL_07.09.2023_clean.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 25 October 2023
File name
Enerzair Breezhaler 114 micrograms46 m_PIL_07.09.2023_clean.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 19 November 2021
File name
Enerzair Breezhaler_REG PIL_PF21-0278_Clean.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.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.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.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.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.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.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)