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Product No EMEA/H/C/000089
Brand Name Caelyx pegylated liposomal
Nonproprietary Name doxorubicin
API doxorubicin hydrochloride
ATC Code L01DB
Indications Caelyx pegylated liposomal 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 (
Orphan Drug no
Generics no
Marketing Authorization Holder Baxter Holding B.V.
Status Authorised(授权)
Authorization Date 1996-06-20
Version 35
Condition Approval no
Exceptions no
Biosimilar no
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