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Apremilast

Extended indication Treatment of psoriatic arthritis, psoriasis, Behçet’s disease
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Apremilast
Domain Chronic immune diseases
Reason of inclusion Generic
Extended indication Treatment of psoriatic arthritis, psoriasis, Behçet’s disease
Current proprietary name Otezla
Mechanism of action Enzyme inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date March 2023
Expected Registration April 2024
Registration phase Registered
Additional remarks Positieve CHMP-opinie februari 2024

Therapeutic value

Therapeutic value No estimate possible yet

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.