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Ciclosporine

Extended indication Ciclosporin in combination with standard therapy for the treatment of bronchiolitis obliterans syndr
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Ciclosporine
Domain Lung diseases
Reason of inclusion Indication extension
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.
Manufacturer Zambon
Budgetting framework Extramural (GVS)
Additional remarks Fabrikant: Zambon. Liposomale cyclosporine A voor inhalatie (L-CsA-i).

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date July 2025
Expected Registration August 2026
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
References NCT03657342 (BOSTON-1); NCT03656926 (BOSTON-2)

Expected patient volume per year

There is currently nothing known about the expected patient volume.

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.