Zolsketil pegylated liposomal
doxorubicin
Table of contents
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.
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List item
Zolsketil pegylated liposomal : EPAR - Medicine overview (PDF/145.99 KB)
First published: 20/06/2022
EMEA/H/C/005320 -
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List item
Zolsketil pegylated liposomal : EPAR - Risk management plan summary (PDF/94.71 KB)
First published: 20/06/2022
Authorisation details
Product details | |
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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) |
|
Anatomical therapeutic chemical (ATC) code |
L01DB01
|
Publication details | |
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Marketing-authorisation holder |
Accord Healthcare S.L.U.
|
Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
31/05/2022
|
Contact address |
Accord Healthcare S.L.U. |
Product information
23/08/2023 Zolsketil pegylated liposomal - EMEA/H/C/005320 - PSUSA/00001172/202211
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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.