Extended indication Extension of indication to include patients from 1 month to 4 years of age for treatment of partial-
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Lacosamide
Domain Neurological disorders
Reason of inclusion Indication extension
Main indication Epilepsy
Extended indication Extension of indication to include patients from 1 month to 4 years of age for treatment of partial-onset seizures with or without secondary generalisation as monotherapy and adjunctive therapy for Vimpat/Lacosamide USB.
Proprietary name Vimpat
Manufacturer UCB
Mechanism of action Other, see general comments
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional comments CRMP2 protein modulator.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date January 2021
Expected Registration November 2021
Orphan drug No
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.