Belatacept

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.
Therapeutic value	No judgement
Registration phase	Registration application pending

Product

Active substance	Belatacept
Domain	Chronic immune diseases
Reason of inclusion	Indication extension
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
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)

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

Therapeutic value	No judgement

There is currently nothing known about the expected patient volume.

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

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.