Bronchitol 40 mg, inhalation powder, hard capsules
*Company:
Pharmaxis Europe 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 27 June 2023
File name
MEDPL-010-01 Ireland-Northern Ireland Bronchitol SmPC - Marketing Version (en).pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 August 2022
File name
MEDPL-014-02 Great Britain, Ireland-Northern Ireland Bronchitol PL - Marketing Version text (en).pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Change to section 6 - manufacturer address ; Change to section 6 - date of revision
Updated on 14 October 2020
File name
20201005 Bronchitol_PIL_EN.pdf
Reasons for updating
- Change in co-marketing arrangement
Updated on 21 January 2020
File name
emea-combined-h1252-en.pdf
Reasons for updating
- Change in co-marketing arrangement
Updated on 10 April 2019
File name
20190225 Bronchitol_PIL_EN.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 10 April 2019
File name
20190225 Bronchitol_SPC_EN.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 30 January 2019
File name
20190123 Bronchitol_PIL_EN - EMC.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 30 January 2019
File name
20190123 Bronchitol_SPC_EN.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update of Marketing Authorisation Holder
Updated on 07 June 2017
File name
PIL_16500_290.pdf
Reasons for updating
- New PIL for new product
Updated on 07 June 2017
Reasons for updating
- Change to section 6 - manufacturer
Updated on 30 January 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 6 - what the product looks like and pack contents
Updated on 29 January 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 29 January 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 19 April 2016
Reasons for updating
- Removal/change of distributor
Updated on 05 April 2016
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
Updated on 04 April 2016
Reasons for updating
- Change to storage instructions
Updated on 28 January 2016
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 07 October 2015
Reasons for updating
- New PIL for medicines.ie