Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1815511
Name of medicinal product: AZACITIDINE MYLAN
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: 7TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Azacitidine Mylan 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):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Mylan Ireland Limited 
Marketing authorization number: EU/1/20/1426 
Marketing authorization issued on: March 27, 2020 
Marketing authorization expires on: March 30, 2025 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: April 9, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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