EMEA-002564-PIP01-19
Key facts
| Active substance |
Ecopipam (hydrochloride)
|
| Therapeutic area |
Psychiatry
|
| Decision number |
P/0351/2019
|
| PIP number |
EMEA-002564-PIP01-19
|
| Pharmaceutical form(s) |
Age-appropriate oral solid dosage form
|
| Condition(s) / indication(s) |
Treatment of Tourette syndrome
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Emalex Biosciences, Inc.
E-mail: fda_emalex@emalexbiosciences.com |
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|