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
Tel. +1 3127773741

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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