Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: AZACITIDINE BETAPHARM
Active substances:
Estonian, English, Latin
ATC code: L01BC07
Dosage form: powder for suspension for injection
Strength: 100mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
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
Marketing authorization holder: Betapharm Arzneimittel GmbH 
Marketing authorization number: EU/1/19/1416 
Marketing authorization issued on: March 24, 2020 
Marketing authorization expires on: March 25, 2025 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1814497  AZACITIDINE BETAPHARM  powder for suspension for injection  100mg 1TK  Prescription      21.02.2024    viaal 
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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