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SMC ID Date Medicine Submission Type Indication
SMC2302 18/01/2021 daratumumab (Darzalex) Full

In combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
SMC2326 18/01/2021 daratumumab (Darzalex) Abbreviated

In combination with bortezomib, thalidomide and dexamethasone is indicated for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
1096/15 07/12/2015 lenalidomide (Revlimid) Full treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
441/08 07/04/2014 lenalidomide (Revlimid) Resubmission In combination with dexamethasone, for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. (This resubmission relates to patients who have received only one prior therapy).
927/13 13/01/2014 bortezomib (Velcade) Full In combination with dexamethasone, or with dexamethasone and thalidomide, for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
822/12 10/12/2012 bortezomib (Velcade) Abbreviated For the treatment of multiple meyeloma (2 indications).
700/11 11/04/2011 bendamustine (Levact) Non submission for the front line treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) in combination with prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or bortezomib containing treatment.
525/08 12/01/2009 thalidomide (Pharmion) Full In combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged ≥65 years or ineligible for high dose chemotherapy

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