Padcev powder for concentrate for solution for infusion
*Company:
Astellas Pharma Co. 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 03 October 2024
File name
IE_NI Padcev PIL v5.0_27-Sep-2024.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 03 October 2024
File name
IE-NI Padcev SmPCv5.0_27-Sep-2024.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 September 2024
File name
IE_NI Padcev PIL v4.0_05092024.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 05 September 2024
File name
IE-NI Padcev SmPCv4.0-05092024.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 August 2024
File name
IE_SmPC_Padcev_EV-302_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 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 August 2024
File name
IE_NI Padcev PIL v3.0 clean-EV-302 only.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
File name
IE_Padcev_PC_4003504_07Apr2022.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Last version only due to format change.
File name
28-Nov-2023_Educational Letter HCPs Patient Info Pack_signed.pdf
Reasons for updating
- Add New Doc
Updated on 04 May 2023
File name
IE_NI Padcev PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 04 May 2023
File name
IE-NI Padcev SmPC.pdf
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 May 2023
File name
IE_NI Padcev PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 23 January 2023
File name
IE-NI Padcev SmPC 01.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Patient Card 4002075 07Apr22_clean copy for EMC.pdf
Reasons for updating
- Add New Doc
Updated on 19 April 2022
File name
IE-NI Padcev SmPC 01.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 April 2022
File name
IE_NI Padcev PIL 01.pdf
Reasons for updating
- New PIL for new product