Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: AZACITIDINE KABI
Active substances:
Azacitidine
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
Labelling:  
Indication: Azacitidine Kabi 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 withoutmyeloproliferative disorder, • Acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia, according toWorld Health Organisation (WHO) classification, • AML with > 30% marrow blasts according to the WHO classification.
Safety features: Yes
Marketing authorization holder: Fresenius Kabi Deutschland GmbH 
Marketing authorization number: EU/1/23/1777 
Marketing authorization issued on: January 9, 2024 
Marketing authorization expires on: January 9, 2029 
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
3064092  AZACITIDINE KABI  powder for suspension for injection  100mg 1TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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