Extended indication Extension of indication to include paediatric use (from 6 months to 17 years) for pulmonary arterial
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Tadalafil
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Main indication Other medication for cardiovascular diseases
Extended indication Extension of indication to include paediatric use (from 6 months to 17 years) for pulmonary arterial hypertension (PAH) (from 6 months to 17 years).
Proprietary name Adcirca
Manufacturer Eli Lilly
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 January 2022
Expected Registration November 2022
Orphan drug No
Registration phase Registration application pending

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

References Medicijnkosten.nl
Additional comments Adcirca tablet filmomhuld 20mg: €10,37 per stuk,.

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.