MHRA-101543-PIP01-24-M01 (update)

Key Facts

Active Substance
Active Substance:
  • SELUMETINIB HYDROGEN SULFATE
Invented Name
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
PIP Number MHRA-101543-PIP01-24-M01 (update)
Pharmaceutical form(s)
  • Capsule, hard
  • Granules
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
  • Treatment of neurofibromatosis type 1
  • Treatment of thyroid cancer
  • Treatment of melanoma
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):SELUMETINIB HYDROGEN SULFATE.pdf
Published Date 06/01/2025