Basic Information
Thalidomide Lipomed
Regulatory Information
EMEA/H/C/005715
September 19, 2022
July 21, 2022
1
May 14, 2024
Company Information
Germany
Hegenheimer Strasse 2 79576 Weil am Rhein
Lipomed GmbH
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication 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).
Overview Summary
Thalidomide Lipomed is a medicine used to treat multiple myeloma (a cancer of the bone marrow) in combination with the cancer medicines melphalan and prednisone in patients who have not been treated for multiple myeloma before. It is used in patients aged 65 years or over, and in younger patients if they cannot be treated with high-dose chemotherapy. It contains the active substance thalidomide. Thalidomide Lipomed is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but with certain differences. While the reference medicine, Thalidomide BMS, is a 50 mg capsule, Thalidomide Lipomed is a 100 mg tablet.