EMEA-002812-PIP02-20-M01 - paediatric investigation plan

Rimegepant

Key facts

• Invented name:
  Vydura
• Active Substance:
  Rimegepant
• Therapeutic area:
  Neurology
• Decision number:
  P/0299/2022
• PIP number:
  EMEA-002812-PIP02-20-M01
• Pharmaceutical form(s):
  Oral lyophilisate
• Condition(s) / indication(s):
  Treatment of migraine headaches
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Biohaven Pharmaceuticals, Inc.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/08/2022

Decision

P/0299/2022 : EMA decision of 10 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for rimegepant (Vydura) (EMEA-002812-PIP02-20-M01)

AdoptedReference Number: EMA/638303/2022