MHRA-101678-PIP01-24

Key Facts

Active Substance
Active Substance:
  • Mirdametinib
Invented Name
  • Not available at present
  • Gomeklio
  • Gomeklio
PIP Number MHRA-101678-PIP01-24
Pharmaceutical form(s)
  • Tablets
  • Capsules, hard
Therapeutic area
  • Neurology
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of neurofibromatosis type 1
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-101678-PIP01-24-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Mirdametinib.pdf
Published Date 02/05/2025