AMGEVITA pre-filled syringe-pre-filled pen (High Concentration)
*Company:
Amgen Ireland LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
File name
Ireland Patient Reminder Adult TH4064 v2.pdf
Reasons for updating
- New EDM File
File name
Ireland Patient Reminder Child TH4064 v2.pdf
Reasons for updating
- New EDM File
Updated on 24 October 2024
File name
ie_xi_amgevita_100mgmlapproved_spc_v38.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 October 2024
File name
ie_xi_amgevita_100mgmlapproved_spc_v38.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of the word "spontaneously" under “Malignancies and lymphoproliferative disorders” part of the section 4.8 of the SmPC
Updated on 30 May 2024
File name
ie_xi_amgevita_100mgml_approved_pfs pil_v36.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL
Updated on 30 May 2024
File name
ie_xi_amgevita_80mgml HC_approved_pfp pil_v36.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL
Updated on 30 May 2024
File name
ie_xi_amgevita_40mgml HC_approved_pfp pil_v36.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL
Updated on 30 May 2024
File name
ie_xi_amgevita_100mgml_approved_spc_v36.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
New SPC