EMEA-001531-PIP01-13-M04

Key facts

Invented name
Hetlioz
Active substance
tasimelteon
Therapeutic area
Neurology
Decision number
P/0215/2018
PIP number
EMEA-001531-PIP01-13-M04
Pharmaceutical form(s)
  • Capsule, hard
  • Age-appropriate liquid form
Condition(s) / indication(s)
Treatment of non-24-hour sleep-wake disorder in the totally blind
Route(s) of administration
Oral use
Contact for public enquiries
Vanda Pharmaceuticals Ltd

E-mail: gunther.birznieks@vandapharma.com 
Tel. +1 2027 343416

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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