Celdoxome pegylated liposomal

Lapsed

This medicine's authorisation has lapsed

doxorubicin hydrochloride

Overview

On 22 September 2025 the marketing authorisation of Celdoxome pegylated liposomal (doxorubicin) ceased to be valid in the European Union (EU).

The cessation of validity is due to the fact that the marketing authorisation holder, Baxter Holding B.V., had not marketed Celdoxome pegylated liposomal in the EU since its initial marketing authorisation. In accordance with provisions of the sunset clause¹, the marketing authorisation of the medicinal product lapsed as the product had not been marketed in any of the EU Member States within three years of its initial authorisation.

Baxter Holding B.V. confirmed that the product had not been marketed due to business reasons.

Celdoxome pegylated liposomal was granted marketing authorisation in the EU on 15 September 2022 for the treatment of breast cancer, ovarian cancer, multiple myeloma, AIDS related Kaposi's sarcoma.

The marketing authorisation was initially valid for a 5-year period.

Celdoxome pegylated liposomal is a hybrid medicine of Adriamycin. There are other medicines containing doxorubicin authorised and marketed in the EU.

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¹Article 14(4) of Regulation (EC) No 726/2004 ("sunset clause")

Celdoxome pegylated liposomal : EPAR - Medicine Overview

Reference Number: EMA/695741/2022

Celdoxome pegylated liposomal : EPAR - Risk management plan summary

Product information

Celdoxome pegylated liposomal : EPAR - Product Information

Celdoxome pegylated liposomal : EPAR - All authorised presentations

Product details

• Name of medicine:
  Celdoxome pegylated liposomal
• Active substance:
  doxorubicin hydrochloride
• International non-proprietary name (INN) or common name:
  doxorubicin hydrochloride
• Therapeutic area (MeSH):
  • Breast Neoplasms
  • Ovarian Neoplasms
  • Multiple Myeloma
  • Sarcoma, Kaposi
• Anatomical therapeutic chemical (ATC) code:
  L01DB01

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Celdoxome pegylated liposomal is indicated in adults:

• as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk.
• or 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.

Celdoxome 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 standard doxorubicin (or other anthracycline).

Authorisation details

• EMA product number:
  EMEA/H/C/005330
• Marketing authorisation holder:
  Baxter Holding B.V.

  Kobaltweg 49; 3542 CE; Utrecht; Netherlands

• Opinion adopted:
  21/07/2022
• Marketing authorisation issued:
  15/09/2022
• Lapse of marketing authorisation:
  22/09/2025
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

Celdoxome pegylated liposomal : EPAR - Procedural steps taken and scientific information after authorisation

Celdoxome pegylated liposomal-H-C-PSUSA-00001172-202211 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/400469/2023

Initial marketing authorisation documents

Celdoxome pegylated liposomal : EPAR - Public Assessment Report

Adopted Reference Number: EMA/685994/2022

CHMP summary of positive opinion for Celdoxome pegylated liposomal

Adopted Reference Number: EMA/CHMP/655859/2022