MHRA-100807-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • RIMEGEPANT SULFATE
Invented Name
Vydura
PIP Number MHRA-100807-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Oral lyophilisate
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of migraine headaches
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):RIMEGEPANT SULFATE.pdf
Published Date 24/08/2023