EMEA-003043-PIP01-21 - paediatric investigation plan
alprazolam
PIPHuman
Key facts
Active Substance
alprazolam
Therapeutic area
Neurology
Decision number
P/0220/2022
PIP number
EMEA-003043-PIP01-21
Pharmaceutical form(s)
Inhalation powder
Condition(s) / indication(s)
Treatment of epileptic seizures
Route(s) of administration
Inhalation use
Contact for public enquiries
UCB Pharma SA.
E-mail: UCBCares.IE@ucb.com Tel.: + 353 14632371
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date
Decision
P/0220/2022 : EMA decision of 10 June 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for alprazolam (EMEA-003043-PIP01-21)