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
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
ATMP No
Submission date December 2022
Expected Registration February 2024
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

Expected patient volume per year

Patiëntvolume is niet van toepassing bij generieke geneesmiddelen of biosimilars.

Expected cost per patient per year

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

Potential total cost per year

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

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.