Extended indication Extension of indication to include treatment of metastatic colorectal cancer in adult patients where
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Tegafur / gimeracil / oteraci
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Colon cancer
Extended indication Extension of indication to include treatment of metastatic colorectal cancer in adult patients where it is not possible to initiate or continue treatment with another fluoropyrimidine.
Proprietary name Teysuno
Manufacturer Nordic Pharma
Mechanism of action Other, see general comments
Budgetting framework Intermural (MSZ)
Additional comments DNA synthese remmer.

Registration

Registration route Centralised (EMA)
Submission date November 2020
Expected Registration September 2021
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No judgement

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

References medicijnkosten.nl
Additional comments Capsule 15MG/4,35MG/11,8MG is € 3,40 per stuk en een capsule van 20MG/5,8MG/15,8MG is € 5,18 per stuk.

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.