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Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1807309
Name of medicinal product: ARSENIC TRIOXIDE ACCORD
Active substances:
Arsenic trioxide
Estonian, English, Latin
ATC code: L01XX27
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 1mg 1ml
Amount in package: 10ml 10TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with: -Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, =< 10 x 103 /µl) in combination with all-trans-retinoic acid (ATRA) -Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene. The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: November 2, 2022
Marketing authorization holder: Accord Healthcare S.L.U. 
Marketing authorization number: EU/1/19/1398 
Marketing authorization issued on: November 14, 2019 
Marketing authorization expires on: November 18, 2024 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: December 18, 2019
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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