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Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1828111
Name of medicinal product: ARSENIC TRIOXIDE MEDAC
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 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Arsenic trioxide medac 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/mcl) in combination with all-trans-retinoic acid (ATRA) -Relapsed/refractory 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 pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RARalpa) 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: Never imported to Estonia
Marketing authorization holder: Medac Gesellschaft für klinische Spezialpräparate mbH 
Marketing authorization number: EU/1/20/1475 
Marketing authorization issued on: September 17, 2020 
Marketing authorization expires on: September 18, 2025 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: October 7, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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