Remsima SC 120 mg solution for injection in pre-filled pen
*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

Updated on 26 May 2025
File name
PIL_Remsima SC 120 mg PF Pen_en_May 2025.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
EU Product Information (PI) update for alignment with reference product.
Package leaflet section 4
Not known:
(…)
- Infection due to a live vaccine because of a weakened immune system.
- Problems following a medical procedure (including infectious and non-infectious problems).
Updated on 26 May 2025
File name
SmPC_Remsima SC 120 mg PFS,PFP_en_May 2025.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)
Free text change information supplied by the pharmaceutical company
EU Product Information (PI) update for alignment with reference product.
SmPC Section 4.4 - Others
There is limited safety experience of infliximab treatment in patients who have undergone surgical procedures, including arthroplasty. The long half life of infliximab should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on infliximab should be closely monitored for infectiousns and non-infectious complications, and appropriate actions should be taken (see section 4.8).
Updated on 09 August 2024
File name
PIL_Remsima SC 120 mg PF Pen_en_Aug 2024.pdf
Reasons for updating
- New PIL for new product
File name
CT-P13 SC 120mg_Patient Reminder Card(IE)_Sep22.pdf
Updated on 09 August 2024
File name
SmPC_Remsima SC 120 mg PFS & PFP_en_Aug 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
New SmPC for medicines.ie
Celltrion Healthcare Ireland Ltd.

Address:
26 Arrow Building, Old Belgard Road, Tallaght, Dublin, D24 ND70Medical Information E-mail:
Medinfoie@celltrionhc.comTelephone:
01 223 4026