Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1508194
Name of medicinal product: DOXORUBICIN ACTAVIS
Active substances:
Estonian, English, Latin
ATC code: L01DB01
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 2mg 1ml
Amount in package: 25ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: /…/ is indicated for the treatment of - Small-cell lung cancer (SCLC) - Breast cancer - Recurrent ovarian carcinoma - Intravesical prophylaxis of recurrences of superficial bladder carcinoma following transurethral resection (TUR) - Systemic treatment of local advanced or metastasized bladder carcinoma - Neoadjuvant and adjuvant therapy of osteosarcoma - Advanced soft-tissue sarcoma in adult age - Ewing's sarcoma - Hodgkin's lymphoma - Highly malignant Non-Hodgkin's lymphoma - Induction and consolidation treatment in acute lymphatic leukaemia - Acute myeloblastic leukaemia - Advanced multiple myeloma - Advanced or recurrent endometrial carcinoma - Wilms' tumour (in stage II in highly malignant variants, in all advanced stages [III - IV]) - Advanced papillary/follicular thyroid cancer - Anaplastic thyroid cancer - Advanced neuroblastoma Doxorubicin is frequently used in combination chemotherapy regimens with other cytostatic agents.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated June 28, 2023)
Package information leaflet (PIL): EST  (last updated June 28, 2023)
Labelling:  (last updated June 28, 2023)
Last imported to Estonia: October 19, 2018
Marketing authorization holder: Actavis Group PTC ehf. 
Marketing authorization number: 769511 
Marketing authorization issued on: December 13, 2011 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: February 16, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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