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Cenegermin

Oxervate

Extended indication Behandeling van matige (persisterend epitheeldefect) of ernstige (cornea ulcus) neurotrofische kerat
Therapeutic value No judgement
Registration phase Registered

Product

Active substance Cenegermin
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Eye disorders
Extended indication Behandeling van matige (persisterend epitheeldefect) of ernstige (cornea ulcus) neurotrofische keratitis bij volwassenen.
Proprietary name Oxervate
Manufacturer Dompé
Route of administration Ocular
Therapeutical formulation Eye drops
Budgetting framework Extramural (GVS)
Additional remarks Werkingsmechanisme: 'Recombinant human nerve growth factor (rhNGF)'.

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Submission date December 2016
Expected Registration July 2017
Orphan drug Yes
Registration phase Registered
Additional remarks Oxervate is per juli 2017 geregistreerd bij de EMA voor Keratitis. Nog geen vergoeding.

Therapeutic value

Therapeutic value No judgement

Expected patient volume per year

References EMA
Additional remarks Neurotrophic keratitis komt voor bij 4.2 in 10,000 inwoners van de EU. Dit zijn 7.140 patiënten per 17 miljoen Nederlanders.

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.