🇪🇺 Lenalidomide and low-dose dexamethasone in European Union

EMA authorised Lenalidomide and low-dose dexamethasone on 14 June 2007

Marketing authorisation

EMA — authorised 14 June 2007

  • Application: EMEA/H/C/000717
  • Marketing authorisation holder: Bristol-Myers Squibb Pharma EEIG
  • Local brand name: Revlimid
  • Indication: Multiple myeloma Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Revlimid as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one
  • Status: approved

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Other Oncology approved in European Union

Frequently asked questions

Is Lenalidomide and low-dose dexamethasone approved in European Union?

Yes. EMA authorised it on 14 June 2007.

Who is the marketing authorisation holder for Lenalidomide and low-dose dexamethasone in European Union?

Bristol-Myers Squibb Pharma EEIG holds the EU marketing authorisation.