Caelyx pegylated liposomal



This medicine is authorised for use in the European Union.


Caelyx pegylated liposomal is a medicine used to treat the following types of cancer in adults:

  • metastatic breast cancer in patients at risk of heart problems. ‘Metastatic’ means the cancer has spread to other parts of the body. Caelyx pegylated liposomal is used on its own for this disease;
  • advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;
  • Kaposi’s sarcoma in patients with AIDS who have very damaged immune system. Kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs;
  • multiple myeloma (a cancer of the cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had a bone marrow transplantation or are unsuitable for it. Caelyx pegylated liposomal is used in combination with bortezomib (another cancer medicine).

Caelyx pegylated liposomal contains the active substance doxorubicin.

This EPAR was last updated on 02/02/2021

Authorisation details

Product details
Caelyx pegylated liposomal
Agency product number
Active substance
doxorubicin hydrochloride
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Sarcoma, Kaposi
  • Multiple Myeloma
  • Ovarian Neoplasms
  • Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Janssen-Cilag International NV
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Turnhoutseweg 30
B-2340 Beerse

Product information

18/01/2021 Caelyx pegylated liposomal - EMEA/H/C/000089 - II/0094


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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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 (<200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.

Caelyx pegylated liposomal 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 standarddoxorubicin (or other anthracycline).

Assessment history

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