Extended indication Extension of indication to include paediatric patients (3 months to 18 years of age) for hepatic and
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Mycofenolaatmofetil
Domain Oncology
Reason of inclusion Indication extension
Extended indication Extension of indication to include paediatric patients (3 months to 18 years of age) for hepatic and cardiac transplants and to extend the indication for renal transplants for paediatric patients starting from 3 months
Manufacturer Roche

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date June 2023
Expected Registration September 2024
Registration phase Registration application pending

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.