🇪🇺 isatuximab SAR650984 IV in European Union

EMA authorised isatuximab SAR650984 IV on 30 May 2020

Marketing authorisation

EMA — authorised 30 May 2020

  • Application: EMEA/H/C/004977
  • Marketing authorisation holder: Sanofi Winthrop Industrie
  • Local brand name: Sarclisa
  • Indication: Sarclisa is indicated:  In combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. In combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. In combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed
  • Status: approved

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isatuximab SAR650984 IV 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 isatuximab SAR650984 IV approved in European Union?

Yes. EMA authorised it on 30 May 2020.

Who is the marketing authorisation holder for isatuximab SAR650984 IV in European Union?

Sanofi Winthrop Industrie holds the EU marketing authorisation.