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Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1139554
Name of medicinal product: CAELYX PEGYLATED LIPOSOMAL
Active substances:
Doxorubicin
Estonian, English, Latin
ATC code: L01DB01
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 2mg 1ml
Amount in package: 10ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Caelyx pegylated liposomal is indicated: -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 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. Caelyx 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
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: July 30, 2021
Marketing authorization holder: Baxter Holding B.V. 
Marketing authorization number: EU/1/96/011 
Marketing authorization issued on: December 5, 2003 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: October 7, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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