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Mycofenolaatmofetil

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.