Melatonin (Circadin) - paediatric investigation plan

melatonin

Key facts

• Invented name:
  • Circadin
  • Circadin
• Active Substance:
  melatonin
• Therapeutic area:
  Neurology
• Decision number:
  P/49/2009
• PIP number:
  Melatonin (Circadin)
• Pharmaceutical form(s):
  Prolonged-release tablet
• Condition(s) / indication(s):
  Primary insomnia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  RAD Neurim Pharmaceuticals EEC Ltd

  E-mail: [e-mail]; Tel.: [phone]

• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  24/03/2009

Decision

P/49/2009: European Medicines Agency decision of 24 March 2009 on the refusal of a product specific waiver for melatonin (Circadin) (EMEA-000440-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European P...

AdoptedReference Number: EMEA/156983/2009