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Intended for UK patients and members of the public

IMULDOSA® Concentrate for Solution for Infusion

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Active Ingredients

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

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IMULDOSA® 130 mg concentrate for solution for infusion (active: ustekinumab)

Medicines showing this symbol are subject to additional monitoring. This will allow quick identification of new safety information. Please click here for more information.

PL Number:
PLGB 20075/1554
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • 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

    SmPC sections updated: 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 and 10

  • 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

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

General FAQs

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