LUMYKRAS
*Company:
Amgen Ireland LtdStatus:
UpdatedLegal 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 28 July 2026
File name
ie_lumykras_approved_spc_cb202_renegotiation_clean.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to add local reporting statement
Updated on 29 June 2026
File name
ie_lumykras_approved_spc_cb202_renegotiation_clean.pdf
Reasons for updating
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Administrative updates
Updated on 10 July 2025
File name
ie_lumykras_approved_spc_CB200combined.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 July 2025
File name
ie_lumykras_approved_pil_v10_dose_comparison.pdf
Reasons for updating
- New PIL for new product
Amgen Ireland Ltd
Address:
21 Northwood Court, Santry, Dublin D09 TX31, Ireland, 216 Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0WA, UKMedical Information E-mail:
gbinfoline@amgen.comTelephone:
+44 (0)1223 420 305Website:
https://www.amgen.co.ukMedical Information Direct Line:
+44 (0)1223 436 441/Freephone: 1800 535160Customer Care direct line:
+44 (0)1223 436441/Freephone: 1800 535160