Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Spravato 28 mg nasal spray, solution.
| Pharmaceutical Form |
|---|
|
Nasal spray, solution. Clear, colourless, aqueous solution. |
Each nasal spray device contains esketamine hydrochloride corresponding to 28 mg esketamine.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Esketamine |
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. |
| List of Excipients |
|---|
|
Citric acid monohydrate |
Type-I glass vial with a chlorobutyl rubber stopper. The filled and stoppered vial is assembled into a manually-activated nasal spray device. The device dispenses two sprays.
Within each pack, each device is individually packaged in a sealed blister.
Pack sizes of 1, 2, 3, or 6 nasal spray devices.
Not all pack sizes may be marketed.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
EU/1/19/1410/001 (1 spray container)
EU/1/19/1410/002 (2 spray containers)
EU/1/19/1410/003 (3 spray containers)
EU/1/19/1410/004 (6 spray containers)
| Drug | Countries | |
|---|---|---|
| SPRAVATO | 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 |
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