Caelyx pegylated liposomal
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.
Caelyx pegylated liposomal : EPAR - Medicine overview (PDF/181.04 KB)
First published: 10/03/2008
Last updated: 02/04/2020
Caelyx pegylated liposomal
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Janssen-Cilag International N.V.
|Date of issue of marketing authorisation valid throughout the European Union||
02/03/2020 Caelyx pegylated liposomal - EMEA/H/C/000089 - N/0093
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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).
European Medicines Agency recommends precautionary recall of remaining batch of Vistide manufactured at Ben Venue Laboratories13/12/2011
European Medicines Agency gives further interim recommendations on dealing with shortcomings in quality assurance at Ben Venue Laboratories09/12/2011
European Medicines Agency gives interim recommendations to deal with shortcomings in quality assurance at Ben Venue Laboratories22/11/2011