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Mirabegron

Betmiga

Extended indication

Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 to less than 18 years.
Therapeutic value

No estimate possible yet
Registration phase

Registration application pending

Product

Active substance

Mirabegron
Domain

Metabolism and Endocrinology
Reason of inclusion

Indication extension
Extended indication

Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 to less than 18 years.
Proprietary name

Betmiga
Manufacturer

Astellas
Route of administration

Oral
Therapeutical formulation

Tablet
Budgetting framework

Extramural (GVS)

Registration

Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
ATMP

No
Submission date

December 2021
Expected Registration

September 2024
Orphan drug

No
Registration phase

Registration application pending

Therapeutic value

Therapeutic value

No estimate possible yet

Expected patient volume per year

References 
Farmacotherapeutisch kompas

Expected cost per patient per year

Cost

< 165.00
References 
medicijnkosten.nl; GIP-databank
Additional remarks 
De kosten per 50mg betreffen €0,90 (inclusief BTW). In 2021 bedroegen bij volwassenen de kosten €163,70 per patiënt per jaar. Mogelijk zal dit bij kinderen minder zijn indien een lagere dosering van toepassing is.

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.