Extended indication Symptomatische behandeling van het Lambert-Eaton-myastheniesyndroom (LEMS) bij volwassenen.
Therapeutic value Possible equal value
Registration phase Registration application pending

Product

Active substance Amifampridine
Domain Neurological disorders
Reason of inclusion Generic
Main indication Muscular diseases other
Extended indication Symptomatische behandeling van het Lambert-Eaton-myastheniesyndroom (LEMS) bij volwassenen.
Current proprietary name Firdapse (SERB SA)
Already available biosimilars / generics geen
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional comments Acetylcholine stimulants; Potassium channel antagonists

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date May 2021
Expected Registration May 2022
Orphan drug No
Registration phase Registration application pending
Additional comments Geen geldig patent gevonden in het octrooi register

Therapeutic value

Therapeutic value Possible equal value

Expected patient volume per year

Patiëntvolume is niet van toepassing bij generieke geneesmiddelen of biosimilars.

Expected cost per patient per year

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

Potential total cost per year

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

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.