In other countries
The same active substances on other registers, the same brand first.
- SpevigoCanada · 300 MG / 2 ML · Solution · Leo Pharma INCSame brand
- SpevigoCanada · 60 MG / ML · Solution · Leo Pharma INCSame brand
- SpevigoCanada · 150 MG / 1 ML · Solution · Leo Pharma INCSame brand
- SpevigoEuropean Union · LEO Pharma A/SSame brand
- SpevigoCroatiaSame brand
- SpevigoItaly · Soluzione iniettabile in siringa pre-riempita · Leo Pharma A/SSame brand
- Spevigo 150 mg, oplossing voor injectie in voorgevulde spuitNetherlands · Oplossing voor injectie · Leo Pharma A/SSame brand
- Spevigo 300 mg, oplossing voor injectie in voorgevulde spuitNetherlands · Oplossing voor injectie · Leo Pharma A/SSame brand
- Spevigo 450 mg concentraat voor oplossing voor infusieNetherlands · Concentraat voor oplossing voor infusie · Leo Pharma A/SSame brand
- Spevigo Concentrate for Solution for Infusion 450 MG/7.5 MLSingapore · 450 mg/7.5ml · infusion, solution concentrate · DKSH Singapore Pte. LTD.Same brand
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.
FDA Purple Book, September 2026 release; acquired 2026-10-10T15:29:54.330165+00:00; exact source fields retained with source-key projections.
Licence: FDA-created structured factual administrative metadata; public-domain policy with third-party exceptions · Added 11 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
- Spesolimab
- Strength
- 300MG/2ML
- Dosage form
- Injection
- Route
- Subcutaneous
- Register
- United States (FDA)
- Status
- Marketed
- Status in the register
- Licensed / Rx
- Authorised
- 28 May 2025
- Registration
- BLA 761244
- Marketing authorisation holder
- LEO Pharma A/S
- Procedure
- 351(a)
- Supply
- Rx