Zolsketil pegylated liposomal

RSS

doxorubicin

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 20/06/2022

Authorisation details

Product details
Name
Zolsketil pegylated liposomal
Agency product number
EMEA/H/C/005320
Active substance
doxorubicin hydrochloride, liposomal
International non-proprietary name (INN) or common name
doxorubicin
Therapeutic area (MeSH)
  • Ovarian Neoplasms
  • Sarcoma, Kaposi
  • Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
L01DB01
Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Date of issue of marketing authorisation valid throughout the European Union
31/05/2022
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

24/03/2022 Zolsketil pegylated liposomal - EMEA/H/C/005320 -

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You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

doxorubicin

Therapeutic 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.

Assessment history

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