Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: CELDOXOME PEGYLATED LIPOSOMAL
Active substances:
Doxorubicin
Estonian, English, Latin
ATC code: L01DB01
Dosage form: concentrate for dispersion for infusion
Strength: 2mg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Celdoxome pegylated liposomal is indicated in adults: - 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 platinumbased 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).
Safety features: Yes
Marketing authorization holder: Baxter Holding B.V. 
Marketing authorization number: EU/1/22/1666 
Marketing authorization issued on: September 15, 2022 
Marketing authorization expires on: September 22, 2027 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
3040759  CELDOXOME PEGYLATED LIPOSOMAL  concentrate for dispersion for infusion  2mg 1ml 10ml 1TK  Prescription           
3040760  CELDOXOME PEGYLATED LIPOSOMAL  concentrate for dispersion for infusion  2mg 1ml 10ml 10TK  Prescription           
3040782  CELDOXOME PEGYLATED LIPOSOMAL  concentrate for dispersion for infusion  2mg 1ml 25ml 1TK  Prescription           
3040793  CELDOXOME PEGYLATED LIPOSOMAL  concentrate for dispersion for infusion  2mg 1ml 25ml 10TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

You can download Acrobat Reader fromhere