EMEA-000440-PIP02-11-M05 - paediatric investigation plan

melatonin

Key facts

• Invented name:
  • Circadin
  • Circadin
• Active Substance:
  melatonin
• Therapeutic area:
  Neurology
• Decision number:
  P/0089/2017
• PIP number:
  EMEA-000440-PIP02-11-M05
• Pharmaceutical form(s):
  • Prolonged-release tablet
  • Age-appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of insomnia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/04/2017
• Compliance procedure number:
  EMEA-000440-PIP02-11-M05
• Compliance opinion date:
  21/04/2017
• Compliance outcome:
  Positive

Decision

P/0089/2017: EMA decision of 6 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for melatonin (Circadin), (EMEA-000440-PIP02-11-M05)

AdoptedReference Number: EMA/208387/2017