EMEA-002121-PIP03-19-M01 - paediatric investigation plan

Daridorexant
PIPHuman

Key facts

Invented name
Quviviq
Active Substance
Daridorexant
Therapeutic area
Psychiatry
Decision number
P/0116/2022
PIP number
EMEA-002121-PIP03-19-M01
Pharmaceutical form(s)
  • Age-appropriate oral solid dosage form
  • Film-coated tablet
Condition(s) / indication(s)
Treatment of insomnia
Route(s) of administration
Oral use
Contact for public enquiries

Idorsia Pharmaceuticals Deutschland GmbH

Tel. +41 588440000
E-mail: clinical-trials-disclosure@idorsia.com

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

Decision

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