Enhertu 100 mg powder for concentrate for solution for infusion
*Company:
Daiichi Sankyo Ireland LtdStatus:
No Recent UpdateLegal 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
Updated on 23 February 2024
File name
enhertu-smpc-ie-v14-240111-clean_no headers.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- 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 23 February 2024
File name
enhertu-pil-ie-v09-2401-clean_no headers.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 14 November 2023
File name
enhertu-smpc-ie-v13-20231109_clean.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
Update to section 5.1 for HER2-low breast cancer to include updated OS data from study U303 (DB04).
Updated on 14 November 2023
File name
enhertu-smpc-ie-v13-20231109_clean.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
Update to section 5.1 for HER2-low breast cancer to include updated OS data from study U303 (DB04).
Updated on 14 November 2023
File name
enhertu-smpc-ie-v13-20231109_clean.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
Update to section 5.1 for HER2-low breast cancer to include updated OS data from study U303 (DB04).
Updated on 14 November 2023
File name
enhertu-smpc-ie-v13-20231109_clean.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
Update to section 5.1 for HER2-low breast cancer to include updated OS data from study U303 (DB04).
Updated on 14 November 2023
File name
enhertu-smpc-ie-v13-20231109_clean.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
Update to section 5.1 to include updated OS data from study U303 (DB04).
Updated on 23 October 2023
File name
enhertu-pil-ie-v08-nsclc-231018.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 23 October 2023
File name
enhertu-smpc-ie-v12-nsclc-231018.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 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)
Free text change information supplied by the pharmaceutical company
New indication - non-small cell lung cancer.
Updated on 21 August 2023
File name
enhertu-pil-ie-v07-mBC-2307.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 21 August 2023
File name
enhertu-smpc-ie-v11-mBC-230706.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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 June 2023
File name
SmPC-Enhertu-v10-transfusion-clean-230526.pdf
Reasons for updating
- 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)
File name
DSE_ENHERTU_HCP_Guide_PoPCME_IE_final0903_view.pdf
Reasons for updating
- Replace File
File name
DSE_ENHERTU_HCP_Guide-ILD_IE_final0903_view.pdf
Reasons for updating
- Replace File
Updated on 31 January 2023
File name
SmPC-Enhertu-V09-(Her2-low)-clean-230123.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
- 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 31 January 2023
File name
PIL-Enhertu-V06 (HER2-low)-clean-230123.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 December 2022
File name
SmPC-Enhertu-V08-(Gastric Cancer)-clean-221212.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
- 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 14 December 2022
File name
PIL-Enhertu-V05-(Gastric Cancer)-clean-221212.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
File name
DSIE RMM_Enhertu_HCP guide PoPCME v2-220926.pdf
Reasons for updating
- Replace File
File name
DSIE RMM_Enhertu_HCP guide ILD v2-220926.pdf
Reasons for updating
- Replace File
File name
DSIE RMM_Enhertu_Patient Card ILD v2-220926.pdf
Reasons for updating
- Replace File
Updated on 15 November 2022
File name
SmPC-Enhertu-V07-(reconstitution + QRD)-clean-221110.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
PIL-Enhertu-V04-(reconstitution + QRD)-clean-221110.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 09 September 2022
File name
SmPC-Enhertu-V06-(nausea_vomiting)-clean-300822.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
PIL-Enhertu-V03-(nausea_vomiting)-clean-300822.pdf
Reasons for updating
- Change to section 3 - how to take/use
Updated on 29 July 2022
File name
PIL-Enhertu-V02-(2LBC)-clean-110722.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
SmPC-Enhertu-V05-(2LBC)-clean-110722.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.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
File name
DSE_ENHERTU_HCP_Guide-ILD_IE_V1-200421.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
V00 - MA grant & HPRA approved
File name
DSE_ENHERTU_HCP_Guide_PoPCME_IE_V1-200421.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
V00 - MA grant & HPRA approved
File name
DSE_ENHERTU_Patient_Card-ILD_IE_V1-200421.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.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