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Letermovir

Prevymis

Extended indication Letermovir monotherapy for prophylactic treatment of cytomegalovirus infection reactivation in newbo
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Letermovir
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication Viral infections other
Extended indication Letermovir monotherapy for prophylactic treatment of cytomegalovirus infection reactivation in newborns, infants and toddlers, children and adolescents who are at risk of developing CMV infection following an allogeneic haematopoietic stem cell transplantation
Proprietary name Prevymis
Manufacturer MSD
Mechanism of action Virus inhibitor
Route of administration Oral
Therapeutical formulation Granulate
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date April 2024
Expected Registration April 2025
Orphan drug No
Registration phase Registration application pending
Additional remarks Verwachte registratie op basis van IHSI-inschatting.

Therapeutic value

Therapeutic value No estimate possible yet
References NCT03940586 (MK-8228-030)

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.