EMEA-002758-PIP01-19-M02 - paediatric investigation plan
Dexmedetomidine hydrochloride
PIPHuman
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)
Treatment of bipolar disorder
Treatment of schizophrenia
Route(s) of administration
Sublingual use
Contact for public enquiries
BioXcel Therapeutics, Inc.
info@bioxceltherapeutics.com
+1 475 2386837
Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Decision
P/0232/2022: EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for sibeprenlimab (EMEA-003085-PIP01-21)