Xtandi 40 mg film-coated tablets
*Company:
Astellas Pharma Co. LtdStatus:
UpdatedLegal 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 25 April 2024
File name
IE-NI Xtandi Tabs SmPC 06 (24-05-2022)_cl.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Current document reinstated.
Updated on 25 April 2024
File name
IE NI SmPC Embark plus PSUR April2024 clean.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of Embark study indication to section 4.1 as follows
"as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high‑risk biochemical recurrent (BCR) non-metastatic hormone‑sensitive prostate cancer (nmHSPC) who are unsuitable for salvage‑radiotherapy"
Administration advice regarding indication added to section 4.2. Safety changes as a result of Embark study added to section 4.4 and 4.8 and details of the study added to section 5.1.
The PSUR outcome also resulted in safety changes relating to severe skin reactions (including Stevens-Johnson syndrome) to section 4.4 and 4.8. Also the addition of adverse event "hepatic enzymes increased" to section 4.8.
Date of revision amended to April 2024
Updated on 04 April 2024
File name
IE-NI Xtandi Tabs PIL 04-2024_Clean_AnD for upload to eMC NI and Meds.ie.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 27 May 2022
File name
IE-NI Xtandi Tabs SmPC 06 (24-05-2022)_cl.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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 27 April 2022
File name
IE-NI Xtandi Tabs SmPC 05 (21-04-2022)_cl.pdf
Reasons for updating
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 April 2022
File name
IE-NI Xtandi Tabs PIL 04-2022_cl.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 05 May 2021
File name
IE_Xtandi 40mg Tabs_PIL_ARCHES & PSUR_cl_Apr21.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 05 May 2021
File name
IE_Xtandi 40mg Tabs_SmPC_ARCHES & PSUR_cl_Apr21.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 22 April 2021
File name
IE_Xtandi Tabs 40 mg_SmPC_Mar2021_cl.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 22 April 2021
File name
IE_Xtandi Tabs 40 mg_PIL_Mar2021_cl.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 25 February 2021
File name
IE_Xtandi Tabs_PIL_Jan2021_cl.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - driving and using machines
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 25 February 2021
File name
IE_Xtandi Tabs_SmPC_Jan2021_cl.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- 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 18 February 2020
File name
Xtandi Tablets_IE_SmPC_Feb2020.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 February 2020
File name
Xtandi Tablets_IE_PIL_Feb2020.pdf
Reasons for updating
- New PIL for new product