Tadalafil

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).
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 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	No estimate possible yet

There is currently nothing known about the expected patient volume.

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

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.