Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: DOXORUBICIN ACTAVIS
Active substances:
Doxorubicin
Estonian, English, Latin
ATC code: L01DB01
Dosage form: concentrate for solution for infusion
Strength: 2mg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated 28 June 2023)
Package information leaflet (PIL): EST  (last updated 28 June 2023)
Labelling:  (last updated 28 June 2023)
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
Marketing authorization holder: Actavis Group PTC ehf. 
Marketing authorization number: 769511 
Marketing authorization issued on: 13 December 2011 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1508150  DOXORUBICIN ACTAVIS  concentrate for solution for infusion  2mg 1ml 5ml 1TK  Prescription           
1508161  DOXORUBICIN ACTAVIS  concentrate for solution for infusion  2mg 1ml 5ml 10TK  Prescription           
1508172  DOXORUBICIN ACTAVIS  concentrate for solution for infusion  2mg 1ml 10ml 1TK  Prescription           
1508183  DOXORUBICIN ACTAVIS  concentrate for solution for infusion  2mg 1ml 10ml 10TK  Prescription      28/10/2014     
1508194  DOXORUBICIN ACTAVIS  concentrate for solution for infusion  2mg 1ml 25ml 1TK  Prescription      19/10/2018     
1508206  DOXORUBICIN ACTAVIS  concentrate for solution for infusion  2mg 1ml 50ml 1TK  Prescription           
1508217  DOXORUBICIN ACTAVIS  concentrate for solution for infusion  2mg 1ml 75ml 1TK  Prescription           
1508228  DOXORUBICIN ACTAVIS  concentrate for solution for infusion  2mg 1ml 100ml 1TK  Prescription      30/03/2020     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription