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

*
Pharmacy Only: Prescription
  • Company:

    Celltrion Healthcare Ireland Ltd.
  • Status:

    Updated
  • Legal 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

qrcode image

Scan the QR code or enter an email to access and share this medicine:

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.

Celltrion Healthcare Ireland Ltd.