Steqeyma 90 mg solution for injection in pre-filled syringe
*Company:
Celltrion Healthcare Ireland Ltd.Status:
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 03 March 2025
File name
PIL_Steqeyma 90mg PFS_en_Jan 2025.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
Free text change information supplied by the pharmaceutical company
In alignment with PI for reference product, based on PSUR, the Steqeyma package leaflet was updated to advise against use of live vaccines (eg, BCG) for 12 months post-partum for infants born to women who received ustekinumab in pregnancy, instead of previously advised 6 months (section 2: “Other medicines, vaccines and Steqeyma”, and “Pregnancy and breast feeding”).
Updated on 06 November 2024
File name
CT-P43 SC 90mg_PFS-S_Leaflet(IE)_ver2.pdf
Reasons for updating
- New PIL for new product
Updated on 06 November 2024
File name
SmPC_Steqeyma 45 & 90 mg PFS_en_Sep2024.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Celltrion Healthcare Ireland Ltd.
Address:
26 Arrow Building, Old Belgard Road, Tallaght, Dublin, D24 ND70Medical Information E-mail:
Medinfoie@celltrionhc.comTelephone:
01 223 4026