Product class: Authorized package
Medicinal product class: For human use
Package code: 1792492
Name of medicinal product: AZACITIDINE AUXILIA
Active substances:
Azacitidine
Estonian, English, Latin
ATC code: L01BC07
Dosage form: powder for suspension for injection
Route of administration: subcutaneous use
Strengh: 100mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: [Product name] is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: • intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), • chronic myelomonocytic leukaemia (CMML) with 10-29 % marrow blasts without myeloproliferative disorder, • acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification, • AML with >30% marrow blasts according to the WHO classification.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated 29 November 2022)
Package information leaflet (PIL): EST  (last updated 03 May 2023)
Labelling:  (last updated 15 September 2021)
Last imported to Estonia: 04 June 2024
Marketing authorization holder: Auxilia Pharma OÜ 
Marketing authorization number: 1038121 
Marketing authorization issued on: 15 September 2021 
Marketing authorization expires on: 15 September 2026 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 03 May 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription