This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Caelyx. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Caelyx.

This EPAR was last updated on 11/10/2019

Authorisation details

Product details
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 N.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Turnhoutseweg 30
B-2340 Beerse

Product information

23/09/2019 Caelyx - EMEA/H/C/000089 - PSUSA/00001172/201811


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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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 standarddoxorubicin (or other anthracycline).

Assessment history

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