🇪🇺 DOXORUBICIN in European Union

EMA authorised DOXORUBICIN on 20 June 1996

Marketing authorisations

Application: EMEA/H/C/000089
Marketing authorisation holder: Baxter Holding B.V.
Local brand name: Caelyx pegylated liposomal
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 ext
Status: approved

Application: EMEA/H/C/000297
Marketing authorisation holder: CHEPLAPHARM Arzneimittel GmbH
Local brand name: Myocet liposomal (previously Myocet)
Indication: Myocet liposomal, in combination with cyclophosphamide, is indicated for the first-line treatment of metastatic breast cancer in adult women.
Status: approved

Application: EMEA/H/C/005194
Marketing authorisation holder: Laboratorios Tillomed Spain S.L.U
Local brand name: Doxorubicin Hydrochloride Tillomed
Indication: Treatment of breast cancer, ovarian cancer, progressive multiple myeloma and AIDS-related Kaposi's sarcoma.
Status: withdrawn

Application: EMEA/H/C/005320
Marketing authorisation holder: Accord Healthcare S.L.U.
Local brand name: Zolsketil pegylated liposomal
Indication: Zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults: • breast cancer that has spread to other parts of the body in patients at risk of heart problems. Zolsketil 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; • multiple myeloma (a cancer of the white blood 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, or are unsuitable f
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is DOXORUBICIN approved in European Union?

Yes. EMA authorised it on 20 June 1996; EMA authorised it on 13 July 2000; EMA authorised it on 13 September 2011.

Who is the marketing authorisation holder for DOXORUBICIN in European Union?

Baxter Holding B.V. holds the EU marketing authorisation.