EMEA-003148-PIP01-21 - paediatric investigation plan
Oxytocin
PIPHuman
Key facts
Active Substance
Oxytocin
Therapeutic area
Endocrinology-Gynaecology-Fertility-Metabolism
Decision number
P/0285/2022
PIP number
EMEA-003148-PIP01-21
Pharmaceutical form(s)
Nasal spray (solution)
Condition(s) / indication(s)
Treatment of Prader-Willi syndrome
Route(s) of administration
Nasal use
Contact for public enquiries
OT4B
E-mail: media@ot4b.com Tel: +33 189164311
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date
Decision
P/0285/2022: EMA decision of 11 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for oxytocin (EMEA-003148-PIP01-21)