EMEA-002758-PIP01-19-M02
Key facts
| Active substance |
Dexmedetomidine hydrochloride
|
| Therapeutic area |
Psychiatry
|
| Decision number |
P/0248/2022
|
| PIP number |
EMEA-002758-PIP01-19-M02
|
| Pharmaceutical form(s) |
Oromucosal film
|
| Condition(s) / indication(s) |
|
| Route(s) of administration |
Sublingual use
|
| Contact for public enquiries |
BioXcel Therapeutics, Inc.
+1 475 2386837 |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|