Extended indication Lichte tot matige idiopathische pulmonale fibrose (IPF) bij volwassenen.
Therapeutic value Possible equal value
Registration phase Registration application pending

Product

Active substance Pirfenidone
Domain Lung diseases
Reason of inclusion Generic G
Main indication Lung other
Extended indication Lichte tot matige idiopathische pulmonale fibrose (IPF) bij volwassenen.
Current proprietary name Esbriet (Roche)
Already available biosimilars / generics geen
Mechanism of action Unknown
Route of administration Oral
Therapeutical formulation Unknown
Budgetting framework Extramural (GVS)
Additional remarks Collagen inhibitors; Cytokine inhibitors

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP No
Submission date May 2021
Expected Registration May 2022
Orphan drug No
Registration phase Registration application pending
Additional remarks Vele patenten geldig, de komende jaren nog allemaal van kracht.

Therapeutic value

Therapeutic value Possible equal value

This assessment does not indicate any potential inclusion in the package.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information