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Pegcetacoplan

Aspaveli

Extended indication Extension of indication to include treatment of adult patients with Paroxysmal Nocturnal Hemoglobinu
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Pegcetacoplan
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Main indication Other non-oncological hematological medications
Extended indication Extension of indication to include treatment of adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously treated with a complement inhibitor
Proprietary name Aspaveli
Manufacturer Sobi
Mechanism of action Complement inhibitor
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date April 2023
Expected Registration February 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.