SPRAVATO

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug SPRAVATO contains one active pharmaceutical ingredient (API):

1 Esketamine UNII L8P1H35P2Z - ESKETAMINE HYDROCHLORIDE

Esketamine, the S-enantiomer of racemic ketamine, is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor. Through NMDA receptor antagonism, esketamine produces a transient increase in glutamate release. Restoration of dopaminergic neurotransmission in brain regions involved in the reward and motivation, and decreased stimulation of brain regions involved in anhedonia, may contribute to the rapid response. Read about Esketamine

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
SPRAVATO Nasal spray, solution	FDA, National Drug Code (US)	MPI, US: SPL/PLR
SPRAVATO Nasal spray, solution	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
N06AX27		N Nervous system → N06 Psychoanaleptics → N06A Antidepressants → N06AX Other antidepressants
Discover more medicines within N06AX27

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 514521030038705, 514521030038805, 514521030038905
Country: CA	Health Products and Food Branch	Identifier(s): 02499290
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 5532-MEE-1020
Country: EE	Ravimiamet	Identifier(s): 1809019, 1809020, 1809031, 1809042, 1840788
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 174271, 449200, 566111
Country: FR	Base de données publique des médicaments	Identifier(s): 67355371
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 385001, 385002, 385003
Country: HK	Department of Health Drug Office	Identifier(s): 67010
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8539, 8738
Country: IT	Agenzia del Farmaco	Identifier(s): 048398010, 048398022, 048398034, 048398046, 048398059, 048398061
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1089085, 1089086, 1089087, 1089088, 1091815
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 207667
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 20520
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100427468
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W66532001, W66532002, W66532003
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699593540011, 8699593540028, 8699593540035
Country: US	FDA, National Drug Code	Identifier(s): 50458-028
Country: ZA	Health Products Regulatory Authority	Identifier(s): 53/1.2/0732