YUFLYMA pre-filled pen & syringe (high concentration)
*Company:
Celltrion Healthcare Ireland Ltd.Status:
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
File name
Yuflyma Paediatric Patient Reminder Card_with dimensions_ver2.0 (March 2026).pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Removal of black triangle and additional monitoring status.
Addition of advisory re endemic fungal infections, and recording of batch numbers.
File name
Yuflyma Adult Patient Reminder Card_with dimensions_ver2.0 (March 2026).pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Removal of black triangle and additional monitoring status.
Addition of advisory re endemic fungal infections, and recording of batch numbers.
Updated on 03 March 2025
File name
SmPC_Yuflyma (all presentations)_11Dec2024.pdf
Reasons for updating
- Addition of joint SPC covering all presentations
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of SmPC for Yuflyma 20 mg pre-filled syringe. Extension of Yuflyma 20mg shelf-life to 33 months.
Updated on 03 March 2025
File name
Yuflyma SC 20mg_PFS_Leaflet(IE)_final_Nov 2023.pdf
Reasons for updating
- New PIL for new product
Updated on 25 October 2024
File name
SmPC_Yuflyma 40mg & 80mg_14Oct2024.pdf.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
Change in the SPC of a biosimilar product following assessment of the same change for the reference product. SmPC update with editorial changes.
Updated on 23 July 2024
File name
SmPC_Yuflyma (all presentations)_en_Apr 2024.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
Added SmPC's to medicines.ie
Updated on 23 July 2024
File name
Yuflyma SC 80mg_AI_Leaflet(IE)_final_Nov 2023.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Added PIL to medicines.ie
Updated on 23 July 2024
File name
Yuflyma SC 40mg_AI_Leaflet(IE)_final_Nov 2023.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Added PIL to medicines.ie
File name
Yuflyma Patient Reminder Card - Paediatric_Version_August 2021.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Add New Doc
File name
Yuflyma Patient Reminder Card - Adult_Version_August 2021.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Add New Doc
Celltrion Healthcare Ireland Ltd.
Address:
26 Arrow Building, Old Belgard Road, Tallaght, Dublin, D24 ND70Medical Information E-mail:
Medinfoie@celltrionhc.comTelephone:
01 223 4026