In other countries
The same active substances on other registers, the same brand first.
- UsrentyEuropean Union · Biosimilar Collaborations Ireland LimitedSame brand
- UsrentyCroatiaSame brand
- Usrenty 130 mg concentraat voor oplossing voor infusieNetherlands · Concentraat voor oplossing voor infusie · Biosimilar Collaborations Ireland LimitedSame brand
- Usrenty 45 mg oplossing voor injectieNetherlands · Oplossing voor injectie · Biosimilar Collaborations Ireland LimitedSame brand
- Usrenty 45 mg oplossing voor injectie in een voorgevulde spuitNetherlands · Oplossing voor injectie · Biosimilar Collaborations Ireland LimitedSame brand
- Imuldosa 130 MG Concentrado Para Solucion Para PerfusionSpain · 5 mg/ml · concentrado para solución para perfusión · Accord Healthcare S.L.U.Same form
- Imuldosa 45 MG Solucion Inyectable en Jeringa PrecargadaSpain · 45 mg · solución inyectable en jeringa precargada · Accord Healthcare S.L.U.Same form
- Imuldosa 90 MG Solucion Inyectable en Jeringa PrecargadaSpain · 90 mg/ml · solución inyectable en jeringa precargada · Accord Healthcare S.L.U.Same form
- StelaraNew Zealand · Inj 90 mg per ml, 1 ml pre-filled syringeSame form
- StelaraNew Zealand · Inj 90 mg per ml, 1 ml prefilled syringeSame form
- StelaraNew Zealand · Inj 130 mg vialSame form
- STELARA 90 mgRomania · 90mg · sol inj. in seringa preumpluta · JanssenSame form
- Stelara®Serbia · 45mg/0.5mL · rastvor za injekciju · PredstavniŠTvo Janssen-Cilag KFT BeogradSame form
- Stelara®Serbia · 90mg · rastvor za injekciju u napunjenom injekcionom špricu · PredstavniŠTvo Janssen-Cilag KFT BeogradSame form
- Stelara®Serbia · 45mg · rastvor za injekciju u napunjenom injekcionom špricu · PredstavniŠTvo Janssen-Cilag KFT BeogradSame form
- STELARA 130MG/26ML Concentrate for solution for infusionSaudi Arabia · Janssen-CilagSame form
- Stelara 45MG/0.5ML Solution for InjectionSaudi Arabia · Baxter Pharmaceutical Solution LLCSame form
- STELARA 90mg/1ml SOLUTION FOR INJECTIONSaudi Arabia · Baxter Pharmaceutical Solution LLCSame form
- Ichalig Solution for Injection in Pre-Filled Syringe 45mg/0.5mlSingapore · 45mg/0.5ml · injection, solution · Sindor Healthcare Pte. LTD.Same form
- Stelara Concentrate for Solution for Infusion 130MG/26MLSingapore · 130mg/vial · infusion, solution concentrate · Johnson & Johnson International (Singapore) Pte LTDSame form
- Stelara Solution for Injection 45mg/0.5 mlSingapore · 45mg/vial · injection, solution · Johnson & Johnson International (Singapore) Pte LTDSame form
- ImuldosaUnited States · 130MG/26ML, 45MG/0.5ML, 90MG/ML · injectable · Accord Biopharma INC.Same form
- OtulfiUnited States · 130MG/26ML, 45MG/0.5ML, 90MG/1ML · injectable · Fresenius Kabi USASame form
- PyzchivaUnited States · 130MG/26ML · injectable · Samsung Bioepis Co LTDSame form
- EpyztekBrazil · Samsung Bioepis br Pharmaceutical ltda.Same substance
- ImuldosaBrazil · Accord Farmacêutica LtdaSame substance
- OtulfiBrazil · Fresenius Kabi Brasil LtdaSame substance
- FinliusCanada · 45 MG / 0.5 ML · Solution · Janssen INCSame substance
- FinliusCanada · 90 MG / 1 ML · Solution · Janssen INCSame substance
- Finlius I.V.Canada · 5 MG / ML · Solution · Janssen INCSame substance
- FymskinaEuropean Union · Formycon AGSame substance
- ImuldosaEuropean Union · Accord Healthcare S.L.U.Same substance
- ImuldosaCroatiaSame substance
- OtulfiCroatiaSame substance
- STELARA 130 mgRomania · 130mg · conc. pt. sol. perf. · JanssenSame substance
- STELARA Concentrate for Solution for Infusion (130 mg/26mL)Taiwan · 注射液劑 · 嬌生股份有限公司Same substance
- Stelara Solution for InjectionTaiwan · 預充填式注射劑 · 嬌生股份有限公司Same substance
- Stelara Solution for InjectionTaiwan · 預充填式注射劑 · 嬌生股份有限公司Same substance
Packs
| Pack | Code | Status |
|---|---|---|
| 45 mg - Soluzione iniettabile - Uso sottocutaneo - Flaconcino (vetro) 0,5 ml (90 mg/ml) - 1 Flaconcino | 052553017 | Autorizzata |
| 45 mg - Soluzione iniettabile - Uso sottocutaneo - Siringa preriempita (vetro) 0,5 ml (90 mg/ml) - 1 siringa preriempita | 052553029 | Autorizzata |
| 90 mg - Soluzione iniettabile - Uso sottocutaneo - Siringa preriempita (vetro) 1,0 ml (90 mg/ml) - 1 siringa preriempita | 052553031 | Autorizzata |
| 130 mg - Concentrato per soluzione per infusione - Uso endovenoso - Flaconcino (vetro) 26 ml (5 mg/ml) - 1 Flaconcino | 052553043 | Autorizzata |
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.
Agenzia Italiana del Farmaco (AIFA), Italy
Agenzia Italiana del Farmaco (AIFA); https://drive.aifa.gov.it/farmaci/confezioni_fornitura.csv; HTTP Last-Modified Mon, 12 Oct 2026 23:02:44 GMT; acquired 2026-10-13T17:21:16.224007+00:00; native fields retained, source identifier and role projections are adaptations.
Licence: CC BY 4.0; AIFA published open-data catalog · Added 13 Oct 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
- Dosage form
- Soluzione iniettabile in siringa pre-riempita
- Register
- Italy (AIFA)
- Status
- Authorised
- Status in the register
- Autorizzata
- Registration
- AIC 052553
- Marketing authorisation holder
- Biosimilar Collaborations Ireland Limited
- ATC code
- L04AC05
- Procedure
- Procedura Centralizzata
- Supply
- Medicinali soggetti a prescrizione medica limitativa, vendibili al pubblico su prescrizione di centri ospedalieri o di specialisti