Riociguat Medicine 04 June 2026 Extended indication Riociguat monotherapy for treatment of Chronic thromboembolic pulmonary hypertension in children over 6 years of age and adults. Therapeutic value Possible equal value Total cost Registration phase Registration application pending Product Active substance Riociguat Domain Lung diseases Reason of inclusion Generic G Main indication Lung diseases other Extended indication Riociguat monotherapy for treatment of Chronic thromboembolic pulmonary hypertension in children over 6 years of age and adults. Current proprietary name Adempas (Bayer) Already available biosimilars / generics Proprietary name Manufacturer Portfolio holder Mechanism of action Vasodilator Route of administration Therapeutical formulation Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Generic ATMP No Submission date October 2025 Expected Registration November 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation generiek Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks