🇪🇺 SATRALIZUMAB in European Union

EMA authorised SATRALIZUMAB on 24 June 2021

Marketing authorisation

EMA — authorised 24 June 2021

  • Application: EMEA/H/C/004788
  • Marketing authorisation holder: Roche Registration GmbH
  • Local brand name: Enspryng
  • Indication: Satralizumab (Enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive.
  • Pathway: orphan
  • Status: approved

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SATRALIZUMAB in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is SATRALIZUMAB approved in European Union?

Yes. EMA authorised it on 24 June 2021.

Who is the marketing authorisation holder for SATRALIZUMAB in European Union?

Roche Registration GmbH holds the EU marketing authorisation.