Enhertu 100 mg powder for concentrate for solution for infusion *
Pharmacy Only: Prescription

  • Company:

    Daiichi Sankyo Ireland Ltd
  • Status:

    Updated
  • 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

EDM Updated on 16 November 2022

File name

6374c8386bc77.pdf

Reasons for updating

  • Replace File

EDM Updated on 16 November 2022

File name

6374c82dca395.pdf

Reasons for updating

  • Replace File

EDM Updated on 16 November 2022

File name

6374c81b8df9a.pdf

Reasons for updating

  • Replace File

Updated on 15 November 2022

File name

63741cfd6371c.pdf

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 15 November 2022

File name

63741a9a85338.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 09 September 2022

File name

631b52f732cee.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 09 September 2022

File name

631b5221af7ea.pdf

Reasons for updating

  • Change to section 3 - how to take/use

Updated on 29 July 2022

File name

62e44febadc92.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
  • Change to information for healthcare professionals

Updated on 29 July 2022

File name

62e44f7abd88d.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 5.2 - Pharmacokinetic properties

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

Updated on 17 June 2021

File name

PIL-Enhertu-V01-(IB shelf life ext + editorial)-300421_1623936641.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Type IB Shelf-life extension & editorial updates

EDM Updated on 17 June 2021

File name

DSE_ENHERTU_HCP_Guide_PoPCME_IE_V1-200421_1623936457.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

V00 - MA grant & HPRA approved

EDM Updated on 17 June 2021

File name

DSE_ENHERTU_HCP_Guide-ILD_IE_V1-200421_1623936457.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

V00 - MA grant & HPRA approved

EDM Updated on 17 June 2021

File name

DSE_ENHERTU_Patient_Card-ILD_IE_V1-200421_1623936457.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

V00 - MA grant & HPRA approved

Updated on 17 June 2021

File name

SmPC-Enhertu-V01-(IB shelf life ext + editorial)-300421_1623936178.pdf

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

Type IB shelf life extension & editorial updates