EMEA-002222-PIP01-17

Key facts

Active substance
1H-Isoindol-1-one,2-[[1-[2-(4-fluorophenyl)-2-oxoethyl]-4-piperidinyl]methyl]-2,3-dihydro-,hydrochloride, hydrate (1:1:2) (MIN-101)
Therapeutic area
Psychiatry
Decision number
P/0303/2017
PIP number
EMEA-002222-PIP01-17
Pharmaceutical form(s)
Gastro-resistant tablet
Condition(s) / indication(s)
Treatment of schizophrenia
Route(s) of administration
Oral use
Contact for public enquiries
Minerva Neurosciences, Inc.
Tel. +1 6176007373
E-mail: info@minervaneurosciences.com
Decision type
RP: decision refers to a refusal on a proposed Paediatric Investigation Plan

Decision

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