Celdoxome pegylated liposomal


doxorubicin hydrochloride

This medicine is authorised for use in the European Union.


Celdoxome 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. Celdoxome 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 previous treatment and have already had a bone marrow transplantation or are unsuitable for it. Celdoxome pegylated liposomal is used in combination with bortezomib (another cancer medicine).

Celdoxome pegylated liposomal contains the active substance doxorubicin.

Celdoxome pegylated liposomal is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but in Celdoxome pegylated liposomal the active substance is enclosed in ‘pegylated liposomes’ (tiny fat particles coated with a substance called polyethylene glycol) while this is not the case for the reference medicine. The reference medicine for Celdoxome pegylated liposomal is Adriamycin.

This EPAR was last updated on 05/09/2023

Authorisation details

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

Basier Strasse 7
61352 Bad Homburg

Product information

23/08/2023 Celdoxome pegylated liposomal - EMEA/H/C/005330 - PSUSA/00001172/202211

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Celdoxome pegylated liposomal is indicated in adults:

  • as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk.
  • or 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.

Celdoxome 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 standard doxorubicin (or other anthracycline).

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