EMEA-002142-PIP01-17 - paediatric investigation plan

trazodone (hydrochloride)

Key facts

• Invented name:
  Trittico and associated names
• Active substance:
  trazodone (hydrochloride)
• Therapeutic area:
  Neurology
• Decision number:
  P/0396/2017
• PIP number:
  EMEA-002142-PIP01-17
• Pharmaceutical form(s):
  Age appropriate oral liquid dosage formulation
• Condition(s) / indication(s):
  Treatment of insomnia
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  19/12/2017
• Compliance check done:
  No

Decision

P/0396/2017: EMA decision of 19 December 2017 on the agreement of a paediatric investigation plan and on the granting of a waiver for trazodone (hydrochloride) (Trittico and associated names) (EMEA-002142-PIP01-17)

Reference Number: EMA/793134/2017