Xospata 40 mg film-coated tablets *
Pharmacy Only: Prescription

  • Company:

    Astellas Pharma Co. Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 02 July 2021

File name

IE_Xospata_SmPC_Jun2021_cl_1625222291.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

EDM Updated on 08 March 2021

File name

Xospata_IE_HCP Brochure_v2 Jan2021_1615212698.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 08 March 2021

File name

Xospata_IE_PAC 163473 without metadata_1615212639.pdf

Reasons for updating

  • Add New Doc

Updated on 11 January 2021

File name

IE_Xospata_SmPC_Jan2021_cl_1610380037.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_1610379885.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_1582022077.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_1581681341.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_1581681307.pdf

Reasons for updating

  • New PIL for new product