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
Yes
Compliance Check Decision Date
Compliance opinion date
03/07/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-101543-PIP01-24-M01-C2

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):SELUMETINIB HYDROGEN SULFATE.pdf
Published Date 16/07/2026