Extended indication Extension of indication to include treatment of paediatric patients with paroxysmal nocturnal haemog
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Ravulizumab
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Main indication Other non-oncological hematological medications
Extended indication Extension of indication to include treatment of paediatric patients with paroxysmal nocturnal haemoglobinuria (PNH) for Ultomiris.
Proprietary name Ultomiris
Manufacturer Alexion
Mechanism of action Complement inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments Monoclonaal antilichaam gericht tegen het C5 complement eiwit.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date January 2021
Expected Registration November 2021
Orphan drug Yes
Registration phase Registration application pending
Additional comments ravulizumab is breed uitgesloten, deze indicatie zal dus ook in de sluis worden geplaatst

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.