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Glycopyrronium

Sialanar

Extended indication Extension of indication to include treatment of children aged from 2 years and older for severe droo
Therapeutic value No estimate possible yet
Registration phase No registration expected

Product

Active substance Glycopyrronium
Domain Neurological disorders
Reason of inclusion Indication extension
Main indication Neurological disorders other
Extended indication Extension of indication to include treatment of children aged from 2 years and older for severe drooling.
Proprietary name Sialanar
Manufacturer Pacira

Registration

Registration route Centralised (EMA)
ATMP No
Submission date February 2024
Expected Registration November 2024
Orphan drug No
Registration phase No registration expected
Additional remarks De fabrikant heeft de MAA in september 2024 teruggetrokken.

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.