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
|