EMEA-001428-PIP03-15-M02
Key facts
| Invented name |
Spravato
|
| Active substance |
Esketamine (hydrochloride)
|
| Therapeutic area |
Psychiatry
|
| Decision number |
P/0136/2022
|
| PIP number |
EMEA-001428-PIP03-15-M02
|
| Pharmaceutical form(s) |
Nasal spray, solution
|
| Condition(s) / indication(s) |
Treatment of major depressive disorder
|
| Route(s) of administration |
Intranasal use
|
| Contact for public enquiries |
Janssen-Cilag International NV
Tel. +32 1460 2111 E-mail: contact@janssen-emea.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|