Xtandi 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):

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

Updated on 21 May 2024

File name

IE NI SmPC Embark plus PSUR April2024 clean.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Minor editorial change to product name (removal of hyphen which was added in error)

Updated on 29 April 2024

File name

IE NI Embark and PSUR outcome PIL clean.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Changes include addition of a new indication resulting from the Embark study and update of safety information following that study. 

The PSUR outcome also resulted in safety changes relating to severe skin reactions (including Stevens-Johnson syndrome) to section 4. Also the addition of adverse event "increased liver enzyme levels" to section 4.

Date of revision 04/2024

Updated on 29 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 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