Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 19 June 2018

Indication(s)

Caelyx is indicated:
- As monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk.
- For treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.
- In combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.
- For treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. Caelyx may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

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More information

Category Value
Agency product number EMEA/H/C/000089
Orphan designation No
Date First Approved 21-06-1996
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Janssen-Cilag International N.V.