Nintedanib

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 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	No estimate possible yet

Patiëntvolume is niet van toepassing bij generieke geneesmiddelen of biosimilars.

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

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

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.