Atectura Breezhaler 125/62.5, 125/127.5 and 125/260 micrograms inhalation powder, hard capsules
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal 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 06 March 2025
File name
Actetura Breezhaler REG SPC PF25-0046 February 2025_clean_IPHA.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 March 2025
File name
Atectura Breezhaler REG PIL PF25-0046_clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
Updated on 17 September 2024
File name
Atectura Breezhaler_REG PIL_PF24-0125_clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to MA holder contact details
Updated on 25 October 2023
File name
Atectura Breezhaler 125 micrograms62.5_PF23-0179_PIL_07.09.2023_clean.pdf
Reasons for updating
- Change to storage instructions
Updated on 25 October 2023
File name
Atectura Breezhaler 125 micrograms62.5_SMPC_PF23-0179_07.09.2023_clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 December 2022
File name
Atectura Breezhaler__REG PIL_October 2022_IPHA.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 19 October 2022
File name
Atectura Breezhaler 125 micrograms62.5_PIL_PF22-0195_10.10.2022_clean_Barcelona.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
Updated on 19 October 2022
File name
Atectura Breezhaler 125 micrograms62.5_SMPC_PF22-0195_10.10.2022_clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 January 2022
File name
Atectura Breezhaler_REG PIL_January 2022_IPHA.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 13 January 2022
File name
Atectura_Breezhaler_REG SPC_January 2022_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)
Updated on 04 May 2021
File name
Atectura Breezhaler_REG PIL_PF 21-0103_Clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to other sources of information section
Updated on 04 May 2021
File name
Atectura_Breezhaler_REG SPC_PF21-0103_April 2021_IPHA.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
- Other
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 March 2021
File name
Atectura_Breezhaler_REG SPC_IPHA.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 30 October 2020
File name
Atectura_Breezhaler_REG SPC_PF20-0075_May 2020_IPHA.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 30 October 2020
File name
Atectura Breezhaler_REG PIL_PF 20-0075_Clean.pdf
Reasons for updating
- New PIL for new product
Novartis Ireland Limited
Address:
Vista Building, Elm Park Business Park, Merrion Road, Dublin 4, IrelandMedical Information E-mail:
medinfo.dublin@novartis.comTelephone:
+353 1 2601255Fax:
+353 1 2601263