STEQEYMA 45 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 20 August 2025
File name
PL_Steqeyma 45mg PFS_EN_Aug 2025.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 2 - excipient warnings
- Change to section 3 - use in children/adolescents
Free text change information supplied by the pharmaceutical company
Alignment with PI of reference product incorporating addition of paediatric Crohn's disease indication & dosing, and polysorbate allergy warning.
Updated on 20 August 2025
File name
SmPC_Steqeyma 45 & 90 mg PFS_EN_v6.0_Aug 2025.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Alignment of Steqeyma SmPC with that of reference product incorporating addition of paediatric Crohn's disease indication & posology, and updated safety information including polysorbate 80 content.
Updated on 03 March 2025
File name
SmPC_Steqeyma 45 & 90 mg PFS_en_Jan 2025.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Alignment of Steqeyma product information (PI) with that of reference product, and editorial changes.
Based on PSUR for reference product, Steqeyma PI 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 (sections 4.5 and 4.6),
- broaden the advice to monitor for the appearance of skin cancer to include melanoma (section 4.4).
Updated on 03 March 2025
File name
PIL_Steqeyma 45mg 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 45mg_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