EMEA-001454-PIP06-23 - paediatric investigation plan

binimetinib

Key facts

• Invented name:
  Mektovi
• Active substance:
  binimetinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0349/2023
• PIP number:
  EMEA-001454-PIP06-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of lung cancer
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/09/2023
• Compliance check done:
  Nu

Decision

P/0349/2023 : EMA decision of 8 September 2023 on the granting of a product specific waiver for binimetinib (Mektovi), (EMEA-001454-PIP06-23)

Reference Number: EMA/380483/2023