SmPC - IMULDOSA® 45 mg solution for injection in pre-filled syringe (active: ustekinumab): Change history
View Summary of Product Characteristics (SmPC - IMULDOSA® 45 mg solution for injection in pre-filled syringe (active: ustekinumab))
Last updated on this site: 06 Mar 2026
Description of update: To extend the indication to include treatment of moderately to severely active Crohn's disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy or have medical contraindications to such therapies. The change follows the approval of the same change for the reference product Stelara. Consequently, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC and the PIL has been updated. Additionally, a minor change has been made in section 4.5 of the SmPC for IMULDOSA 45 mg solution for injection in prefilled syringe and IMULDOSA 90 mg solution for injection in pre-filled syringe.
Date of approval: 16/02/2026
SmPC sections updated: 4.1, 4.2, 4.4, 4.5 (not 130mg), 4.8, 5.1, 5.2 and 10
Last updated on this site: 06 Mar 2026
Description of update: To extend the indication to include treatment of moderately to severely active Crohn's disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy or have medical contraindications to such therapies. The change follows the approval of the same change for the reference product Stelara. Consequently, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC and the PIL has been updated. Additionally, a minor change has been made in section 4.5 of the SmPC for IMULDOSA 45 mg solution for injection in prefilled syringe and IMULDOSA 90 mg solution for injection in pre-filled syringe.
Date of approval: 16/02/2026
SmPC sections updated: 4.1, 4.2, 4.4, 4.5 (not 130mg), 4.8, 5.1, 5.2 and 10
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Changes: (Updated: 06 Mar 2026)
Description of update: To extend the indication to include treatment of moderately to severely active Crohn's disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy or have medical contraindications to such therapies. The change follows the approval of the same change for the reference product Stelara. Consequently, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC and the PIL has been updated. Additionally, a minor change has been made in section 4.5 of the SmPC for IMULDOSA 45 mg solution for injection in prefilled syringe and IMULDOSA 90 mg solution for injection in pre-filled syringe.
Date of approval: 16/02/2026
SmPC sections updated: 4.1, 4.2, 4.4, 4.5 (not 130mg), 4.8, 5.1, 5.2 and 10
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Changes: (Updated: 26 Mar 2025)
New product launch. Launch date 24/03/2025.