EMEA-001454-PIP03-15-M03 - paediatric investigation plan

binimetinib

Key facts

• Invented name:
  Mektovi
• Active substance:
  binimetinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0147/2023
• PIP number:
  EMEA-001454-PIP03-15-M03
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of melanoma
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/04/2023
• Compliance check done:
  Oui
• Compliance procedure number:
  EMEA-C-001454-PIP03-15-M03
• Compliance opinion date:
  26/04/2024
• Compliance outcome:
  Positive

Decision

P/0147/2023 : EMA decision of 21 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for binimetinib (Mektovi), (EMEA-001454-PIP03-15-M03)

Reference Number: EMA/170329/2023