EMEA-002959-PIP01-21 - paediatric investigation plan

sumatriptan

naproxen (sodium)

Key facts

• Active Substance:
  • sumatriptan
  • naproxen (sodium)
• Therapeutic area:
  Neurology
• Decision number:
  P/0208/2021
• PIP number:
  EMEA-002959-PIP01-21
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of migraine headaches
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Orion Corporation

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/05/2021

Decision

P/0208/2021 : EMA decision of 10 May 2021 on the granting of a product specific waiver for sumatriptan / naproxen (sodium) (EMEA-002959-PIP01-21)

AdoptedReference Number: EMA/244109/2021