Thalidomide

Thalidomide (Thalidomide BMS (previously Thalidomide Celgene), Thalidomide Lipomed) has 1 EU-approved indication in 1 tumour type.

Approved indications of Thalidomide
Biomarker requirement	Regimen	Setting	Conditions

Multiple myeloma1
None	+ melphalan and prednisone	1L	Aged ≥ 65 years or ineligible for high dose chemotherapy

Full text of section 4.1 (therapeutic indications)

Thalidomide Lipomed

Thalidomide Lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy. Thalidomide Lipomed is prescribed and dispensed in accordance with the Thalidomide Lipomed Pregnancy Prevention Programme (see section 4.4).

Thalidomide BMS (previously Thalidomide Celgene)

Thalidomide BMS in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy. Thalidomide BMS is prescribed and dispensed according to the Thalidomide BMS Pregnancy Prevention Programme (see section 4.4).

Label history

42 changes to the Thalidomide BMS (previously Thalidomide Celgene) label since 2008, none of them to the indications. Newest first, in the words of EMA's record of each procedure.