EMEA-002812-PIP01-20 - paediatric investigation plan

Rimegepant

Key facts

• Active Substance:
  Rimegepant
• Therapeutic area:
  Neurology
• Decision number:
  P/0285/2020
• PIP number:
  EMEA-002812-PIP01-20
• Pharmaceutical form(s):
  Orodispersible tablet
• Condition(s) / indication(s):
  Prevention of migraine headaches
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/08/2020

Decision

P/0285/2020 : EMA decision of 12 August 2020 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for rimegepant (EMEA-002812-PIP01-20)

AdoptedReference Number: EMA/388663/2020