XGEVA 120 mg solution for injection in pre-filled syringe
*Company:
Amgen Ireland 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 11 December 2024
File name
ie_xgeva_approved_spc_v86.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)
Free text change information supplied by the pharmaceutical company
Section 6.3: Shelf Life of Vial presentation update from 3 years to 4 years.
Updated on 24 October 2024
File name
ie_xgeva_approved_pil_pfs_v84.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 24 October 2024
File name
ie_xgeva_approved_spc_v84.pdf
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
XGEVA Patient Reminder Card IE fold out-clean (3).pdf
Reasons for updating
- Add New Doc
Updated on 22 May 2024
File name
ie_xi_xgeva_approved_pil_pfs_v82.pdf
Reasons for updating
- New PIL for new product
Updated on 22 May 2024
File name
ie_xi_xgeva_approved_spc_v82.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)