Expand all sections

Pirfenidone

Esbriet

Extended indication Extension of indication to include the treatment of unclassifiable interstitial lung disease (UILD)
Therapeutic value No estimate possible yet
Registration phase No registration expected

Product

Active substance Pirfenidone
Domain Lung diseases
Reason of inclusion Indication extension
Main indication Lung diseases other
Extended indication Extension of indication to include the treatment of unclassifiable interstitial lung disease (UILD) for Esbrie.
Proprietary name Esbriet
Manufacturer Roche
Mechanism of action Other, see general comments
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Collagen inhibitor; Cytokine inhibitor

Registration

Registration route Centralised (EMA)
Submission date January 2021
Orphan drug Yes
Registration phase No registration expected
Additional remarks De registratieaanvraag van deze nieuwe indicatie van Esbriet is door de registratiehouder ingetrokken.

Therapeutic value

Therapeutic value No estimate possible yet

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.