Zolsketil pegylated liposomal (doxorubicin)
- Region
- 🇪🇺 EU
- Active substance
- doxorubicin
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Ovarian Neoplasms; Sarcoma, Kaposi; Multiple Myeloma
- CHMP opinion
- Thu 24 Mar 2022
- EU approval
- Tue 31 May 2022
- Application
- EMEA/H/C/005320
- ATC
- L01DB01
- Official record
- www.ema.europa.eu
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 for, a bone marrow transplantation. Zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine); • Kaposi’s sarcoma in patients with AIDS who have a 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. Zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance called Adriamycin. However, in Zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for Adriamycin.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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- 🇪🇺 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- 🇪🇺 Doxorubicin Hydrochloride Tillomed Application withdrawn · Laboratorios Tillomed Spain S.L.U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- 🇪🇺 Doxorubicin SUN Application withdrawn · Sun Pharmaceutical Industries Europe B.V.
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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.