Product class: Authorized package
Medicinal product class: For human use
Package code: 1814497
Name of medicinal product: AZACITIDINE BETAPHARM
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: viaal
Indication: Azacitidine betapharm 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 % to 29 % marrow blasts without myeloproliferative disorder, * acute myeloid leukaemia (AML) with 20 % to 30 % blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification, * AML with > 30 % marrow blasts according to the WHO classification.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: 21 February 2024
Marketing authorization holder: Betapharm Arzneimittel GmbH 
Marketing authorization number: EU/1/19/1416 
Marketing authorization issued on: 24 March 2020 
Marketing authorization expires on: 25 March 2025 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 17 April 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription