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Macitentan / tadalafil

Extended indication

Patients With Pulmonary Arterial Hypertension
Therapeutic value

Possible benefit in ease of use
Registration phase

Clinical trials

Product

Active substance

Macitentan / tadalafil
Domain

Cardiovascular diseases
Reason of inclusion

New medicine (specialité)
Main indication

Other medication for cardiovascular diseases
Extended indication

Patients With Pulmonary Arterial Hypertension
Manufacturer

Actelion
Budgetting framework

Extramural (GVS)
Additional remarks 
Endothelin A receptor antagonist

Registration

Registration route

Centralised (EMA)
Submission date

2022
Expected Registration

2023
Orphan drug

Yes
Registration phase

Clinical trials

Therapeutic value

Current treatment options

Macitentan en tadalafil worden ook los voorgeschreven.
Therapeutic value

Possible benefit in ease of use
Duration of treatment

continuous
Frequency of administration

1 times a day
Dosage per administration

10mg en 40mg
References 
NCT03904693
Additional remarks 
Film-coated tablet with 10mg macitentan and 40mg tadalafil, to be administered orally once daily.

Expected patient volume per year

Patient volume

255 - 884

Market share is generally not included unless otherwise stated.
References 
ntvg.nl
Additional remarks 
De prevalentie van PAH in Nederland is ongeveer 15-52 per 1.000.000 inwoners.

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.