Osmohale Inhalation Powder, Hard Capsule
*Company:
Pharmaxis Europe LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 13 January 2025
File name
MEDPL-076-02 Ireland Osmohale SmPC - Marketing version text (en).pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to Section 4.8 - Undesirable effects - how to report a side effect to comply with Windsor Framework requirements
Updated on 27 June 2023
File name
MEDPL-076-01 Ireland Osmohale SmPC - Marketing version text (en).pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2023
File name
MEDPL-078-02 Ireland Osmohale PIL - Marketing Version text (en).pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
MIAS Pharma Limited address has been updated.
Updated on 21 March 2019
File name
20190315-Osmohale-pil-ie.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 21 March 2019
File name
20190315-Osmohale-spc-ie.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 February 2016
File name
PIL_16611_497.pdf
Reasons for updating
- New PIL for new product
Pharmaxis Europe Limited
Address:
108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, IrelandMedical Information E-mail:
medical.information@arnapharma.comTelephone:
+353 (0) 1 431 9816