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Decitabine / cedazuridine

Inaqovi

Extended indication Extension of indication to include treatment of adult patients with myelodysplastic syndromes (MDS)
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Decitabine / cedazuridine
Domain Oncology
Reason of inclusion Indication extension
Extended indication Extension of indication to include treatment of adult patients with myelodysplastic syndromes (MDS) and treatment of adult patients with chronic myelomonocytic leukaemia (CMML).
Proprietary name Inaqovi
Manufacturer Otsuka
Route of administration Oral
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date January 2024
Expected Registration November 2024
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.