Caelyx pegylated liposomal (doxorubicin)
- Region
- 🇪🇺 EU
- Active substance
- doxorubicin
- Company
- Baxter Holding B.V.
- Status
- Authorised
- Therapeutic area
- Sarcoma, Kaposi; Multiple Myeloma; Ovarian Neoplasms; Breast Neoplasms
- CHMP opinion
- Thu 15 Feb 1996
- EU approval
- Thu 20 Jun 1996
- Application
- EMEA/H/C/000089
- ATC
- L01DB
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Zolsketil pegylated liposomal Authorised · Accord Healthcare S.L.U.
- 🇺🇸 Oxderys Approved · Avyxa Holdings
- 🇪🇺 Celdoxome pegylated liposomal Lapsed · Baxter Holding B.V.
- 🇪🇺 Myocet liposomal (previously Myocet) Authorised · CHEPLAPHARM Arzneimittel GmbH
- 🇪🇺 Doxorubicin Hydrochloride Tillomed Application withdrawn · Laboratorios Tillomed Spain S.L.U
- 🇪🇺 Doxolipad Refused · TLC Biopharmaceuticals B.V.
- 🇪🇺 Doxorubicin SUN Application withdrawn · Sun Pharmaceutical Industries Europe B.V.
Follow Caelyx pegylated liposomal
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.