Extended indication Extension of indication to include the use of belatacept in conversion from a calcinerin inhibitor -based regimen to a belatacept-based regimen post t
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Belatacept
Domain Chronic immune diseases
Reason of inclusion Indication extension IND
Main indication Other chronic immune diseases
Extended indication Extension of indication to include the use of belatacept in conversion from a calcinerin inhibitor -based regimen to a belatacept-based regimen post transplantation.
Proprietary name Nulojix
Manufacturer BMS
Mechanism of action Unknown
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP Unknown
Submission date August 2020
Expected Registration June 2021
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No judgement

This assessment does not indicate any potential inclusion in the package.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Additional remarks NULOJIX, 250 mg POEDER VOOR OPLOSSING VOOR INFUSIE 250MG € 483,04.

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information