Ciclosporine Medicine 03 June 2025 Extended indication Ciclosporin in combination with standard therapy for the treatment of bronchiolitis obliterans syndrome in adults and the elderly after lung transplantation. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Ciclosporine Domain Lung diseases Reason of inclusion Indication extension IND Main indication Lung diseases other Extended indication Ciclosporin in combination with standard therapy for the treatment of bronchiolitis obliterans syndrome in adults and the elderly after lung transplantation. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Zambon Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Fabrikant: Zambon. Liposomale cyclosporine A voor inhalatie (L-CsA-i). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date July 2025 Expected Registration August 2026 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03657342 (BOSTON-1); NCT03656926 (BOSTON-2) 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks