MHRA-100985-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • BINIMETINIB
Invented Name
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
PIP Number MHRA-100985-PIP01-23-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • 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
19/09/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-100985-PIP01-23-M01-C

Decision Document

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