Agomelatine

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.
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 remarks	selectieve en specifieke agonist van de melatonine receptoren MT1 en MT2

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	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

There is currently nothing known about the expected patient volume.

There is currently nothing known about the expected cost.

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.