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 psoriasis Imuldosa is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A). Paediatric plaque psoriasis Imuldosa is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Psoriatic arthritis (PsA) Imuldosa, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease- modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
In other countries
The same active substances on other registers, the same brand first.
National listings
The national registers that list this EU medicine.
- Imuldosa 130 MG Concentrado Para Solucion Para PerfusionSpain · 5 mg/mlMarketed
- Imuldosa 45 MG Solucion Inyectable en Jeringa PrecargadaSpain · 45 mgMarketed
- Imuldosa 90 MG Solucion Inyectable en Jeringa PrecargadaSpain · 90 mg/mlMarketed
- IMULDOSA 130 mg concentraat voor oplossing voor infusieNetherlandsAuthorised
- IMULDOSA 45 mg oplossing voor injectie in een voorgevulde spuitNetherlandsAuthorised
- IMULDOSA 90 mg oplossing voor injectie in een voorgevulde spuitNetherlandsAuthorised
- ImuldosaBrazil · Accord Farmacêutica LtdaSame brand
- ImuldosaCanada · 90 MG / 1 ML · Solution · Accord Healthcare INCSame brand
- ImuldosaCanada · 45 MG / 0.5 ML · Solution · Accord Healthcare INCSame brand
- Imuldosa IVCanada · 5 MG / ML · Solution · Accord Healthcare INCSame brand
- Imuldosa 130 MG Concentrado Para Solucion Para PerfusionSpain · 5 mg/ml · concentrado para solución para perfusión · Accord Healthcare S.L.U.Same brand
- Imuldosa 45 MG Solucion Inyectable en Jeringa PrecargadaSpain · 45 mg · solución inyectable en jeringa precargada · Accord Healthcare S.L.U.Same brand
- Imuldosa 90 MG Solucion Inyectable en Jeringa PrecargadaSpain · 90 mg/ml · solución inyectable en jeringa precargada · Accord Healthcare S.L.U.Same brand
- ImuldosaCroatiaSame brand
- ImuldosaItaly · Soluzione iniettabile in siringa pre-riempita · Accord Healthcare, S.L.U.Same brand
- IMULDOSA 130 mg concentraat voor oplossing voor infusieNetherlands · Concentraat voor oplossing voor infusie · Accord Healthcare S.L.U.Same brand
- IMULDOSA 45 mg oplossing voor injectie in een voorgevulde spuitNetherlands · Oplossing voor injectie · Accord Healthcare S.L.U.Same brand
- IMULDOSA 90 mg oplossing voor injectie in een voorgevulde spuitNetherlands · Oplossing voor injectie · Accord Healthcare S.L.U.Same brand
- ImuldosaUnited States · 130MG/26ML, 45MG/0.5ML, 90MG/ML · injectable · Accord Biopharma INC.Same brand
- EpyztekBrazil · Samsung Bioepis br Pharmaceutical ltda.Same form
- OtulfiBrazil · Fresenius Kabi Brasil LtdaSame form
- OtulfiCroatiaSame form
- PyzchivaCroatiaSame form
- STELARA 130 mgRomania · 130mg · conc. pt. sol. perf. · JanssenSame form
- STELARA Concentrate for Solution for Infusion (130 mg/26mL)Taiwan · 注射液劑 · 嬌生股份有限公司Same form
- Stelara Solution for InjectionTaiwan · 預充填式注射劑 · 嬌生股份有限公司Same form
- Stelara Solution for InjectionTaiwan · 預充填式注射劑 · 嬌生股份有限公司Same form
- FymskinaItaly · Soluzione iniettabile in siringa pre-riempita · Formycon AGSame substance
- OtulfiItaly · Soluzione iniettabile in siringa pre-riempita · Fresenius Kabi Deutschland GMBHSame substance
- StelaraNew Zealand · Inj 130 mg vialSame substance
- StelaraNew Zealand · Inj 90 mg per ml, 1 ml prefilled syringeSame substance
- StelaraNew Zealand · Inj 90 mg per ml, 1 ml pre-filled syringeSame substance
- STELARA 90 mgRomania · 90mg · sol inj. in seringa preumpluta · JanssenSame substance
- Stelara®Serbia · 45mg · rastvor za injekciju u napunjenom injekcionom špricu · PredstavniŠTvo Janssen-Cilag KFT BeogradSame substance
- Stelara®Serbia · 45mg/0.5mL · rastvor za injekciju · PredstavniŠTvo Janssen-Cilag KFT BeogradSame substance
- Stelara®Serbia · 90mg · rastvor za injekciju u napunjenom injekcionom špricu · PredstavniŠTvo Janssen-Cilag KFT BeogradSame substance
- STELARA 130MG/26ML Concentrate for solution for infusionSaudi Arabia · Janssen-CilagSame substance
- Stelara 45MG/0.5ML Solution for InjectionSaudi Arabia · Baxter Pharmaceutical Solution LLCSame substance
- STELARA 90mg/1ml SOLUTION FOR INJECTIONSaudi Arabia · Baxter Pharmaceutical Solution LLCSame substance
- Ichalig Solution for Injection in Pre-Filled Syringe 45mg/0.5mlSingapore · 45mg/0.5ml · injection, solution · Sindor Healthcare Pte. LTD.Same substance
- Stelara Concentrate for Solution for Infusion 130MG/26MLSingapore · 130mg/vial · infusion, solution concentrate · Johnson & Johnson International (Singapore) Pte LTDSame substance
- Stelara Solution for Injection 45mg/0.5 mlSingapore · 45mg/vial · injection, solution · Johnson & Johnson International (Singapore) Pte LTDSame substance
- OtulfiUnited States · 130MG/26ML, 45MG/0.5ML, 90MG/1ML · injectable · Fresenius Kabi USASame substance
- PyzchivaUnited States · 130MG/26ML · injectable · Samsung Bioepis Co LTDSame substance
Documents
The official texts, at the regulator.
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
Source: European Medicines Agency, EPAR list (imported 10 June 2026).
Licence: EMA content, reuse with acknowledgement · Added 10 Jun 2026
Report an error or request removalCorrections from the holder or the register are welcome.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Active substance
- Ustekinumab
- Register
- European Union (EMA)
- Status
- Authorised
- Authorised
- 12 Dec 2024
- Registration
- EMEA/H/C/006221
- Marketing authorisation holder
- Accord Healthcare S.L.U.
- ATC code
- L04AC05
- Therapeutic area
- Crohn Disease;Psoriasis;Arthritis, Psoriatic
- Procedure
- EU centralised
- EMA product number
- EMEA/H/C/006221



