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Eculizumab

Soliris

Extended indication Extension of indication to include treatment of paediatric patients with refractory generalised myas
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Eculizumab
Domain Neurological disorders
Reason of inclusion Indication extension
Main indication Muscular diseases other
Extended indication Extension of indication to include treatment of paediatric patients with refractory generalised myasthenia gravis (gMG).
Proprietary name Soliris
Manufacturer Alexion
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date November 2022
Expected Registration September 2023
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.