SPRAVATO

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

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 more about Esketamine

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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