PIL - IMULDOSA® 130 mg concentrate for solution for infusion (active: ustekinumab): Change history
View Patient Information Leaflet (PIL - IMULDOSA® 130 mg concentrate for solution for infusion (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.
Date of approval: 16/02/2026
PIL sections updated: 1, 2, 3, 6 and HCP section
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.
Date of approval: 16/02/2026
PIL sections updated: 1, 2, 3, 6 and HCP section
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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.
Date of approval: 16/02/2026
PIL sections updated: 1, 2, 3, 6 and HCP section
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Changes: (Updated: 11 Apr 2025)
New Product Launch. Launch date 10/04/2025.