EMA — authorised 12 December 2024
- Application: EMEA/H/C/006221
- Marketing authorisation holder: Accord Healthcare S.L.U.
- Local brand name: Imuldosa
- Indication: Adult Crohn’s Disease Imuldosa is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. Paediatric Crohn’s Disease Imuldosa is indicated for the 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. Plaque p
- Pathway: biosimilar
- Status: approved
The European Medicines Agency (EMA) granted marketing authorisation for IMULDOSA on 12 December 2024. IMULDOSA is indicated for the treatment of adult and paediatric patients with moderately to severely active Crohn's disease, moderate to severe plaque psoriasis, and active psoriatic arthritis. The approval is based on the biosimilar pathway, and Accord Healthcare S.L.U. is the marketing authorisation holder.