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Sirolimus

Extended indication Treatment of angiofibroma associated with tuberous sclerosis complex
Therapeutic value Possible equal value
Registration phase Registration application pending

Product

Active substance Sirolimus
Domain Chronic immune diseases
Reason of inclusion Generic
Main indication Skin diseases
Extended indication Treatment of angiofibroma associated with tuberous sclerosis complex
Current proprietary name Rapamune (Pfizer)
Route of administration Cutaneous
Therapeutical formulation Gel
Budgetting framework Extramural (GVS)
Additional remarks mTOR remmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date December 2021
Expected Registration March 2023
Orphan drug Yes
Registration phase Registration application pending
Additional remarks Geen geldig SPC bekend.

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.