Extended indication Extension of indication to include treatment of pulmonary arterial hypertension (PAH) in paediatric
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Riociguat
Domain Lung diseases
Reason of inclusion Indication extension
Main indication Lung diseases other
Extended indication Extension of indication to include treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged 6 to less than 18 years of age with WHO Functional Class (FC) I to III in combination with endothelin receptor antagonists with or without prostanoids for ADEMPAS
Proprietary name Adempas
Manufacturer Bayer
Portfolio holder Bayer
Mechanism of action Vasodilator
Route of administration Oral
Therapeutical formulation Coated tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date September 2022
Expected Registration July 2023
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

References ntvg.nl
Additional comments De prevalentie van PAH in Nederland is ongeveer 15-52 per 1.000.000 inwoners.

Expected cost per patient per year

References farmacotherapeutisch kompas
Additional comments Adempas, tablet 2 mg: € 70,05

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.