Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1861219
Name of medicinal product: AZACITIDINE ICG FARMA
Active substances:
Estonian, English, Latin
ATC code: L01BC07
Dosage form: powder for suspension for injection
Route of administration: subcutaneous use
Strengh: 25mg 1ml
Amount in package: 4ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Azacitidine 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 October 9, 2023)
Package information leaflet (PIL): EST  (last updated October 9, 2023)
Labelling:  (last updated October 9, 2023)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Icg Farma UAB 
Marketing authorization number: 1129623 
Marketing authorization issued on: October 9, 2023 
Marketing authorization expires on: October 9, 2028 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 5, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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