Extended indication Extension of indication to include new therapeutic indication in adolescents aged 12 to 17 years for
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Agomelatine
Domain Neurological disorders
Reason of inclusion Indication extension
Main indication Depression
Extended indication Extension of indication to include new therapeutic indication in adolescents aged 12 to 17 years for the treatment of moderate to severe major depressive episodes, if depression is unresponsive to psychological therapy alone.
Proprietary name Valdoxan
Manufacturer Servier
Mechanism of action Receptor agonist
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional comments selectieve en specifieke agonist van de melatonine receptoren MT1 en MT2

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date October 2022
Expected Registration September 2023
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Duration of treatment Average 12 week / weeks
Frequency of administration 1 times a day
Dosage per administration 25 mg
References EudraCT, 2015-002181-23

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.