Agomelatine Medicine 07 December 2022 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 Total cost Registration phase Registration application pending Product Active substance Agomelatine Domain Neurological disorders Reason of inclusion Indication extension IND 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. Current proprietary name Already available biosimilars / generics Proprietary name Valdoxan Manufacturer Servier Portfolio holder Mechanism of action Receptor agonist Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks selectieve en specifieke agonist van de melatonine receptoren MT1 en MT2 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date October 2022 Expected Registration September 2023 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 12 week / weeks Frequency of administration 1 times a day Dosage per administration 25 mg References EudraCT, 2015-002181-23 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks