Xospata 40 mg film-coated tablets
*Company:
Astellas Pharma Co. LtdStatus:
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
File name
Gilteritinib_HCP Educational Information Brochure_IRE_V4.0_APR2024_FINAL.pdf
Reasons for updating
- Replace File
Updated on 01 July 2024
File name
IE_XOSPATA_JUN2024_SmPC.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 July 2024
File name
IE_XOSPATA_JUN2024_PL.pdf
Reasons for updating
- New PIL for medicines.ie
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 05 April 2024
File name
IE-NI_Xospata_PIL_Apr_2024-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 08 November 2023
File name
IE-Xospata SmPC_12OCT_cl.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 January 2023
File name
IE_Xospata_SmPC_Jun2021_cl.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Gilteritinib_HCP Educational Information Brochure_IRE_V3.0_DEC2022.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Change of company address for Astellas Pharma Co., Ltd in contact details section.
Updated on 02 July 2021
File name
IE_Xospata_SmPC_Jun2021_cl.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change of ATC Code from L01XE54 to L01EX13
File name
Xospata_IE_HCP Brochure_v2 Jan2021.pdf
Reasons for updating
- Add New Doc
File name
Xospata_IE_PAC 163473 without metadata.pdf
Reasons for updating
- Add New Doc
Updated on 11 January 2021
File name
IE_Xospata_SmPC_Jan2021_cl.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 January 2021
File name
IE_Xospata_PIL_Jan2021_cl.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
Updated on 18 February 2020
File name
IE_Xospata_PIL_Oct19.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 14 February 2020
File name
IE_Xospata_SmPC_Oct19.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 February 2020
File name
IE_Xospata_PIL_Oct19.pdf
Reasons for updating
- New PIL for new product