Extended indication Treatment of non-small cell lung cancer (NSCLC)
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Nintedanib
Domain Oncology
Reason of inclusion Generic G
Main indication Lung cancer
Extended indication Treatment of non-small cell lung cancer (NSCLC)
Current proprietary name Ofev
Manufacturer Boehringer Ingelheim
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Centre of expertise ILD expertisecentrum St. Antoniusziekenhuis Nieuwegein, EMC Rotterdam, OLVG Amsterdam

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP No
Submission date December 2022
Expected Registration February 2024
Orphan drug Unknown
Registration phase Registration application pending
Additional remarks Het SPC met nummer 300725 verloopt op 8 oktober 2025

Therapeutic value

Therapeutic value No estimate possible yet

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